It is our mission to secure Indiana’s position as a global leader in life sciences by advocating, connecting, promoting, and delivering tangible benefits on behalf of our diverse corporate members.

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Get Ready!! You're Invited!

The Indiana Health Industry Forum is becoming the Indiana Life Sciences Association!

Please join us on Wednesday, October 9th as we celebrate the launch of our new brand, unveil our new logo, and look back at 30 years of service to Indiana's life sciences industry.

Welcome Kate Tew! New IHIF Director of Member Services!

Kate Tew is our recently appointed Director of Member Services. With an extensive background in marketing, advertising, sales, and bookkeeping, she will be spearheading our membership drives and providing support for our communications and events. In addition, she will take charge of maintaining our member database and overseeing bookkeeping tasks. Welcome, Kate!

Don't Miss This IHIF Member Benefit!!

Access to capital is the #1 issue we hear from our members, so we are offering you a NEW member-only service to help you access non-dilutive funding from the government. By teaming up with G2G Consulting, which has secured over $528 million in government funding since 2007, you will receive a monthly report on life sciences grants and a monthly webinar with government funding experts to ask questions and gain insights on how to obtain funding. This Government Biosciences Grant Report or GBG Report is updated and published monthly with all life sciences opportunities spanning from NIH to BARDA to DoD to USDA to NSF to ARPA-H included.

Learn More

Not an IHIF Member? Sign up here to access this benefit and more!

Life Science Executives,

On Demand

BiotechExec provides life science companies with the strategic business solutions and talent needed to bring their life-changing, life-saving products to the market.

TIP: Will your company be participating in trade shows or partnering events this year? Investors and strategics generally accept meetings with people they know before they take meetings with people they don’t know.  Consider adding an experienced Business Development exec from BiotechExec with their established contacts and industry relationships. Leveraging their network can help your company get broad visibility and establish meaningful connections, to optimize the event experience and investment in time and cost.

Learn More! Contact: Steve Joseph, VP Business Development, Biotech Exec

https://biotechexec.com/

News From Around the Industry

Congratulations to Kyle Mohler / Insignum AgTech and John Foglesong / Grannus Therapeutics for winning their respective $1M RALLY IN Prize competitions! Onwards and upwards!

IU names first leader for Institute for Human Health and Wellbeing

A leading researcher in the neuroscience of addiction has been named the inaugural executive director of the Institute for Human Health and Wellbeing at IU Indianapolis. Stephen Boehm is a professor at IU Indianapolis, chairman of the department of psychology and a primary faculty member in the Stark Neurosciences Research Institute. More

FDA Updates Guidance to Further Empower Companies to Address the Spread of Misinformation

Last month, the FDA opted to advance their efforts to ensure the public has access to accurate, up-to-date information regarding FDA regulated medical products related to maintaining and improving public health. Their updated recommendations will empower pharma industry leaders to voluntarily address misinformation related to FDA approved medical products. Their revised draft guidance also includes pathways to information channels which companies may use to address product misinformation. Read the recent press release to learn more about their efforts to address misinformation. 

‘Silent’ mutations found to have repercussions beyond their own gene

Researchers from the University of Notre Dame are adding new evidence to the emerging concept that "silent" or synonymous mutations may have crucial consequences. Their study, published in the Proceedings of the National Academy of Sciences, showed how a synonymous mutation in one gene can significantly affect a neighboring gene, increasing its protein production. Read More

MBX Biosciences files intention to go public

MBX Biosciences Inc. is a company in a hurry. Just three weeks after announcing it had raised $63.5 million in a round of private funding, the Carmel-based company has filed paperwork to go public. More

Groups seek consensus on best way to test medical AI

Few developers of AI tools for use in medical settings have published the results of randomized clinical trials, but hundreds of AI-powered medical devices have received regulatory clearance for use in hospitals and clinics, leaving health care providers in a quandary. Validating AI tools is challenging, and some institutions and groups are seeking consensus as to the best, most rigorous evaluation methods.

Full Story: Nature (8/21)  

Are you developing ground-breaking cancer technology? The newly released FY2025 SBIR Contract Solicitation can help propel your innovation toward commercialization.

This opportunity provides early-stage funding to small businesses developing cancer technologies in priority areas identified by the National Cancer Institute.

FY2025 SBIR Contract Solicitation topics include:

• NIH/NCI 466 - Novel Delivery Systems for RNA-based Cancer Vaccines
• NIH/NCI 467 - Development of Cancer Immunoprevention Agents
• NIH/NCI 468 - Synthetic Microbes (Excluding Oncolytic Viruses) for Immuno-Oncology Therapies
• NIH/NCI 469 - Development of Novel Therapeutics for HPV-related Precancer
• NIH/NCI 470 - Precision Nutrition Interventions to Reduce Cancer-Related Symptoms
• NIH/NCI 471 - Drug-Loaded Carrier Particles for Improved Oral Delivery for Colon Cancer Prevention
• NIH/NCI 472 - Antibody-Drug Conjugates as Radiopharmaceutical Theranostics for Cancer
• NIH/NCI 473 - Point of Care Detection of Antibodies Against HPV16/18 E6 and E7 Oncoproteins in Oropharyngeal Cancer
• NIH/NCI 474 - Point of Care Technologies for GI Cancer Prevention and Early Detection
• NIH/NCI 475 - Development of Digital Biomarkers and Endpoints for Clinical Cancer Care
• NIH/NCI 476 - Digital Twin Software for Optimization of Cancer Radiation Therapy
• NIH/NCI 477 - Wearable Technologies to Facilitate Remote Monitoring of Cancer Patients Following Treatment
• NIH/NCI 478 - Advanced Biomaterials to Improve Cancer Modeling for Research

To learn more about this funding opportunity and associated NCI topic areas, watch the webinar recording.



The deadline to submit a proposal for this opportunity is Friday, October 18, 2024, at 5:00 p.m. ET. For more information, please visit the Current Contracts page or contact Tanya Renwick, contract analyst for the Office of Acquisitions, at ncioasbir@mail.nih.gov. 

With BIO Business Solutions (BBS), IHIF members are eligible for discounts and savings on a wide variety of products and services geared towards life sciences companies and general business needs. From lab supplies, waste removal and insurance, to office supplies and credit cards, there is something here for every company. Explore your options and enjoy the benefits of being an IHIF member!

Featured Program

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BIO Business Solutions provides cost-savings offers to eligible IHIF Members. To learn more about the programs and services available, please click here. Not an IHIF member? Join today!

IHIF Membership

Be sure to check out the new IHIF Member Directory featuring company descriptions and an alphabetical listing.

Welcome New IHIF Members!

We’re building the most patient-friendly way to access clinical trials. Our team @ Power believes that every patient deserves the chance to participate in a life changing clinical trial. Directory Link

Continuity Pharma is a spin-out from the lab of Prof. David H. Thompson at Purdue University. We leverage innovative chemistry and flow technology to improve quality, safety and sustainability in the pharmaceutical industry by developing advanced manufacturing processes for small molecule active pharmaceutical ingredients (API). Using our technology, our customers can drive down costs, and bring high-quality products to market faster and cheaper. Directory Link

At EchoTech, we've developed a comprehensive autonomous vision platform. Our initial product, Magic Mode, is designed to enhance the lives of powered wheelchair users. We believe everyone deserves the freedom and confidence to explore their surroundings without limitations, and that's precisely what Magic Mode delivers. Directory Link

HabitHalo was founded by a former vaper who struggled with control and realized existing methods needed to be updated and made specifically for vapers. HabitHalo is the result of this collective dedication, packaged conveniently in an app that personalizes to each vaper and automates restrictions through our vape compatible hardware device. Directory Link

EIG's mission is to develop highly accurate and non-invasive multi-omic molecular testing solutions for complex diseases like cancer. The company has developed a Multi-omic Integration Platform that combines detection of DNA, RNA, protein and metabolite targets into a single assay. This breakthrough approach transforms the field of molecular diagnostics by offering unparalleled accuracy with comprehensive insights for early disease detection. Directory Link

ScyTek Biotech Life Sciences manufactures diagnostic reagents, special stains, antibodies, hematology, immunohistochemistry, buffers, microbiology, hematoxlyn, etc. Directory Link

Simplicity. Flexibility. Scalability.

We aim to help innovators move faster getting their medical devices to market. Building lean systems and processes along the way to support changing needs and markets. We want to embed ourselves in your business to support long term goals and help grow your team's skills. Directory Link

Krauter Cleanrooms is an Indianapolis based design build company specializing in cost effective modular construction. From controlled lab space to ISO and USP rated facilities. Krauter Cleanrooms is a one stop local source that delivers: Consulting / Design services, Sales / Technical / Engineering Support, Expert Installation, Partnerships with Sub-Trades and Suppliers for turn-key solutions Directory Link

Helmer Scientific provides medical-grade, temperature controlled storage and processing solutions and services for pharmacy, blood bank, laboratory and research. Directory Link

Cushman & Wakefield is a leading global real estate services firm that helps clients transform the way people work, shop and live. It has some 45,000 employees in more than 70 countries.

Our life sciences real estate experts drive customized, dynamic solutions for investors, owners, developers and occupiers within the quickly evolving life sciences sector. Directory Link

Output Medical designs FDA registered medical devices that automate urine output measurements for critically ill patients at high risk of decreased kidney function. We initially target patients with substance use dependency who present with a drug overdose in acute care settings. The current standards rely upon manual methods of urine output measurement which are inaccurate, time consuming, and cannot trend the urine output – all of which adversely affect the quality of patient care. Directory Link

Element is a global Testing Inspection and Certification (TIC) company headquartered in London. It specialises in materials testing and provision of certification schemes in building material, aerospace, transportation, health sciences, oil and gas, and fire protection. Directory Link

PragmaClin is developing digital approaches to managing Parkinson's Disease. PragmaClin aims to help patients with Parkinson's Disease monitor their condition with the use of our flagship software, PRIMS. We want a world where patients can get help faster, with more accurate results. Directory Link

Grannus is an early-stage oncology drug development company, with a unique approach to a well-validated target, the chaperone protein Hsp90, that has demonstrated efficacy in clinical studies but known limitations that have prevented previous drugs from being approved. By selectively targeting individual isoforms, or versions, of Hsp90, Grannus has overcome the limitations of the previous failed programs, and unlocked opportunity across multiple tumor types as a single therapy and in combination with other approved drugs. Directory Link

Our global team designs, manufactures and markets effective, innovative solutions that support orthopedic surgeons and clinicians in restoring mobility, alleviating pain and improving the quality of life for patients around the world. Directory Link

As a member benefit, IHIF is pleased to share and highlight member company news! Please send press releases to info@ihif.org.

Novartis begins construction of two new radioligand therapy facilities in the US, expanding its world-class RLT manufacturing and supply network

Novartis today announced the construction of two new radioligand therapy (RLT) manufacturing facilities in the US that will extend its world-class manufacturing and supply chain capabilities. The new facilities represent Novartis' continued investment in developing a robust infrastructure to support the expanding use of RLTs to treat cancer.

Novartis broke ground on a new facility at its Indianapolis site that will produce radioisotopes critical for the manufacturing of RLTs. In Carlsbad, Calif., Novartis is establishing its third RLT manufacturing site in the US to support expanded use of RLTs, create resiliency in its manufacturing network and optimize the delivery of medicines to patients on the West Coast.

Read More

HabitHalo Inc has officially opened its $1M Pre-seed Fundraise

HabitHalo is actively searching for VC or Angel Investors that have a personal or professional connection to helping stop the epidemic of vaping and nicotine use. 

If you are interested in participating, please reach out to phil@habithalo.com with a short blurb on why the vaping epidemic matters to you. 

Learn more at habithalo.com

Singota Solutions Announces -40 °C Pallet Storage Offering in EU 

Singota Solutions, a leading Contract Development and Manufacturing Organization (CDMO), proudly announces the expansion of its service offerings by adding a new -40 °C and -20°C state-of-the-art pallet storage facility located just outside Milan, Italy. This strategic expansion underscores Singota's commitment to providing unparalleled logistics and 3PL solutions to clients worldwide.



For more information about Singota Solutions and our new European capabilities, please visit www.singota.com, or contact solutions@singota.com.

Attention Big Thinkers - Boomerang Studio Application Now Open

We would love to hear from entrepreneurs using digital technologies to solve important problems in human healthcare. Current areas of interest include administration efficiencies, nursing staffing, strengthening mental health, and much more!

Studio Application

'We’re pretty prolific': Lilly Catalyze360 looks to connect with emerging biotechs across 'all areas'

As Eli Lilly continues to capitalize on its trove of Mounjaro and Zepbound cash with major outside deals, the company’s early external innovation and collaboration arm, Lilly Catalyze360, is welcoming all comers into the fold.

Source: Fierce Biotech - Read More

What We're Following at Home and on the Hill

• Find your legislators and keep up with IHIF's advocacy efforts - here
• Policy Forum Members: Session Updates and Bill Tracker (2024 Session)

IHIF Actions:

• IHIF joined a sign-on letter to Congressional leadership to encourage reauthorization of Pediatric Rare Disease Priority Review Vouchers
• IHIF and our strategic partners reached out to Indiana's Senators to share concerns about measures threatening Intellectual Property Rights
• Click here to see all of the topics and issues IHIF is monitoring

Bringing transformative therapies to patients via innovative payment arrangements

Cutting-edge therapies like cell and gene treatments offer significant benefits but challenge traditional payment systems due to their high costs. Most of these therapies will be covered by government-sponsored insurance, placing a strain on state budgets. To address this, states are adopting innovative payment models, such as value-based agreements and cost-spreading measures, with new legislation like the Medicaid VBPs for Patients Act supporting these approaches to ensure broader access without overwhelming financial constraints.

Full Story: Bio News (8/19)  

R&D Amortization Bill Fails to Pass Senate

The Senate was unable to advance a bipartisan package to that included ending the R&E tax in Section 174 of our tax code that the House passed by 357-70 on January 31, 2024. It would have promoted American small business innovation and growth by allowing full expensing of R&D costs. Instead up to 90% of grants companies are awarded is taxable. Failure to act means it is harder for U.S. small businesses to compete globally and higher costs for things like new equipment and innovative research, which also means businesses are forced to shutdown and jobs are lost.

Contact your Member of Congress to ask that they finally eliminate the Innovation Tax: (202) 224-3121 or send messages via www.Senate.gov that can link you to your senator's website.



(Shared from our partners at G2G Consulting)

Ways and Means Field Hearing – Policymakers Must Take a Balanced, Bipartisan Approach to Life Sciences M&A

The U.S. House Committee on Ways and Means recently held a field hearing in Salt Lake City, UT: “Access to Health Care in America: Unleashing Medical Innovation and Economic Prosperity.” While discussing the many challenges and unique market dynamics that shape life sciences innovation, witnesses – including Kelvyn Cullimore, CEO of PULSE partner BioUtah – emphasized the unique role that mergers and acquisitions (M&A) play in allowing companies of all sizes to advance new treatments and cures to patients.

Read More

AdvaMed Statement on Final TCET Notice

WASHINGTON – AdvaMed, the Medtech Association, released the following statement from President and CEO Scott Whitaker on the final Transitional Coverage for Emerging Technologies (TCET) notice from the Centers for Medicare and Medicaid Services (CMS):

“The final TCET notice is a step toward a stronger, more robust policy, but doesn’t go far enough to help the Medicare seniors depending on breakthrough diagnostics and treatments to alleviate their suffering. The limited number of devices CMS can handle demonstrates clearly to Congress the need for greater resources at CMS. And the exclusion of diagnostics is disappointing, particularly considering the potential for a breakthrough diagnostic technology to save not only lives but costs to the health care system overall through earlier detection. While we appreciate that CMS has released the rule, we call on Congress to finish the job by passing HR 1691, the Ensuring Access to Critical Breakthrough Products Act. Too many patients in need of breakthrough diagnoses and treatments are counting on it.”

• G2G Consulting Monthly Non-Dilutive Gov't Funding Webinar - September 19 (noon) Register



• Purdue Life Sciences and Pharma Career Fair - October 10 - Learn More

• BioCrossroads Indiana Life Sciences Summit - November 7 - More

Tuesday, September 17, 2024

11:30 am - 1:00 pm

Location: Barnes & Thornburg LLP

11 S. Meridian Street, Indianapolis, IN 46204

 Cyber Preparedness: The Best Defense Is a Good Offense

When it comes to issues that can stop your business in its tracks, any kind of cyberattack or breach is at the top of the list. Yet, many companies are either unprepared or underestimate the type of response that may be required. Advance planning mitigates risk, centers trust, and addresses regulatory requirements.

Please join us as our panel outlines key elements of a proactive and comprehensive cyber strategy and shares tools that can help you manage in a rapidly shifting environment. Having a robust, scalable, incident response plan provides peace of mind and direction when something goes awry.

There will not be a Zoom option for this session.

Welcome – Deborah Pollack-Milgate, Partner, Barnes & Thornburg and Kristin Jones, President and CEO, IHIF

Moderator – Brian McGinnis, Partner, Barnes & Thornburg

Panelists: 

• David Shenberger, Belay Station Advisors
• John Boomershine, Vice President Security and Compliance, BlackInk IT
• Stephen Ferrell, Chief Strategy Officer, StrikeGraph
• 
  

There is no charge to participate.

FDA Webinars

October 9, 2024 ICH M12 Drug-Drug Interaction Studies Final Guidance

• This webinar will discuss the ICH M12 Drug Interaction Studies guidance which is the first globally harmonized regulatory guidance on assessments of pharmacokinetic drug interactions mediated by metabolic enzymes and drug transporters. The guidance describes a systemic approach to evaluation of the drug interaction potential of investigational drugs during drug development and regulatory review.

October 16, 2024 Global IDMP Implementation - Getting Closer to the Goal

• Attend this webinar to learn how Identification of Medicinal Products (IDMP) offers a global framework for the unique identification and consistent documentation of medicinal products, facilitating effective information exchange among regulators, manufacturers, suppliers, and distributors. Once fully adopted, these standards will enhance pharmacovigilance, address drug shortages, and improve medication safety worldwide.

Join the world’s top medtech executives at the leading medical technology event.

IHIF Members Use Promo Code for a 10% Discount MEDTECHCONSPOJOINUS10

The MedTech Conference in Toronto, Canada, October 15-17, 2024, will help you look ahead and create new possibilities. Featuring world-class speakers, a cross-cutting educational program, invaluable networking and next-level technology, this forum for transformational ideas is a can’t-miss event for the industry’s prominent and most promising companies.

Medtech's momentum is transforming health care, making this the perfect moment to join the global medtech community in Toronto at The MedTech Conference. With advancements in technology, increased investment, and a global focus on innovation, medtech is now leading the charge in shaping the future of health care.

Our industry is making rapid strides in AI, robotics, wearable devices, telemedicine, and personalized medicine—innovations that are enhancing patient care and making health care more accessible. As we stand at the forefront of these changes, there’s no better time to be part of this transformation.

Learn More

BioCentury Grand Rounds Conference

September 9-11, 2024

Nashville, TN

15% Discount Using Code GR24IHIF15 for IHIF’s network. Applicable to general registration as well as Poster or Startup Presentations.

BioCentury Grand Rounds will provide an interdisciplinary forum of top academic, investor, biotech and pharma R&D leaders that will showcase groundbreaking research, clinical insights and transformative technologies with significant commercial potential.

This conference, BioCentury’s first dedicated R&D meeting, will focus on the most upstream part of the drug development continuum, the academia/industry interface.

Grand Rounds Nashville will bring together academic innovators and physician scientists with VCs and pharmas looking for breakthrough discoveries and technologies, and provide a forum to discuss critical issues in translation. A particular goal is to give investors access to innovators they do not normally meet, and likewise enable those entrepreneurs to find avenues to commercialize their discoveries.