Montana receives federal tech hub designation, money to advance photonics industry

By Isabel Hicks Chronicle Staff Writer

 October 24, 2023 

Montana is set to receive $450,000 and the opportunity to compete for millions in private and federal grants after receiving the federal designation of Regional Tech Hub. Designation of the Montana Headwaters Regional Technology and Innovation Hub will focus on supporting workforce development and jobs in the photonics, optics and autonomous systems industries. The technologies are important for natural resource management, agriculture, disaster prevention applications and defense.

The hub designation comes as part of the bipartisan CHIPS and Science Act that Congress passed last year to invest in high-tech jobs and research across the country. The Montana hub is one of 31 tech hub designations awarded to states and regions across the county.

The $450,000 will go to Accelerate Montana, an economic development consortium based in Missoula, to help plan the hub’s launch and figure out funding opportunities for Montana. Being designated as a tech hub opens the doors for phase two funding through the CHIPS and Science Act, which Montana plans to apply for in February 2024, said Accelerate Montana Director Paul Gladen in an interview Tuesday.

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Tonix Pharmaceuticals Announces Enrollment Initiated in Mass General Brigham Phase 2 Investigator-Initiated Study of TNX-1900 (Intranasal Potentiated Oxytocin) for Bone Health in Children with Autism Spectrum Disorder

Children with Autism Spectrum Disorder are at Risk for Low Bone Density Preliminary Data Suggest that the Administration of Oxytocin May Favorably Impact Bone Formation and Strength

Recent Meta-Analysis Reported that Plasma Oxytocin Levels Tend to be Lower in Children with Autism Spectrum Disorder than Controls

Press Release

November 13, 2023

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the first participant was enrolled in an investigator-initiated Phase 2 study of TNX-1900 (intranasal potentiated oxytocin) for improving bone health in children with autism spectrum disorder (ASD), named the BOX study, at Massachusetts General Hospital (MGH). The aim of this Department of Defense-funded study is to investigate the efficacy and safety of TNX-1900 as a novel therapeutic agent to increase bone density and improve bone structure and strength in children with ASD. Tonix is providing active drug and placebo for the BOX study as part of a drug donation agreement with MGH. MGH is the sponsor of the trial, which is being conducted under an investigator-initiated investigational new drug (IND) application.

“Low bone density in ASD is a serious problem,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Intranasal potentiated oxytocin is a potential treatment option that addresses the biology of bone loss specific to ASD which is different from osteoporosis in post-menopausal women. Intranasal oxytocin has a long history of being tested for the treatment of ASD, but results have been inconsistent. Tonix’s magnesium-potentiated intranasal oxytocin is designed to improve consistency in clinical effects, because it reduces the ‘high-dose’ inhibition seen in the ‘inverted U’ dose response in animals.”



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FYR Diagnostics Welcomes Dr. Kirk Tanner and Dr. Andy Hill to its Scientific Advisory Board

Press Release

November 28, 2023

FYR Diagnostics, a pioneering company in the development of liquid biopsy technologies, is thrilled to announce the addition of Dr. Kirk Tanner and Dr. Andy Hill to its Scientific Advisory Board (SAB).

Dr. Kirk Tanner is the current Chief Scientific Officer at the National Brain Tumor Society. Formerly, he was the Research Oncology Disease Area Expert and Senior Director at Vertex Pharmaceuticals. With over two decades of experience in oncology research and a history of success in discovery and development projects, Dr. Tanner brings a wealth of knowledge and a unique perspective to the FYR Dx team. His background will be instrumental in advancing FYR's liquid biopsy technologies, equipping pharmaceutical companies with the necessary tools for successful clinical trials. His expertise in oncology research will be key to advancing FYR's liquid biopsy technologies for the specific demands and challenges of clinical trial settings, ensuring that pharmaceutical companies have the best possible tools at their disposal.

...

Dr. Andy Hill, an internationally renowned researcher in the field of neurodegenerative disorders and extracellular vesicles (EVs), brings a wealth of knowledge and experience to FYR Diagnostics. His groundbreaking work in the field of EVs will provide valuable insights into FYR Dx's innovative approach to liquid biopsies. Dr. Hill has held prestigious positions such as President of the International Society for Extracellular Vesicles (2016-2020), and he is the current Editor in Chief of the Journal of Extracellular Biology.

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Tonix Pharmaceuticals Completes Clinical Stage of Phase 3 RESILIENT Study of TNX-102 SL for the Management of Fibromyalgia

Topline results expected late December 2023

RESILIENT is expected to be the final efficacy trial required for submission of a New Drug Application to FDA; first successful Phase 3 trial, RELIEF, achieved statistical significance (p=0.010)

Preliminary unaudited rate of adverse-event (AE) related discontinuations in the RESILIENT study was 4.8% which compares favorably with prior studies: RELIEF 6.0% and RALLY 10.7%

TNX-102 SL is a centrally acting, non-opioid analgesic

Press Release

November 15, 2023

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the completion of the clinical phase of the Phase 3 registration-quality, double-blind, placebo-controlled RESILIENT1 study of TNX-102 SL2 (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the management of fibromyalgia. A total of 457 patients were enrolled in this multi-site study in the U.S. Topline results are expected in late December 2023. If successful, it is expected to be the final, well-controlled efficacy trial required for submission of a New Drug Application (NDA) for approval by the U.S. Food and Drug Administration (FDA).

“There are an estimated 6-12 million individuals in the U.S. suffering from this debilitating condition, most of whom are women,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TNX-102 SL is a centrally-acting, non-opioid analgesic bedtime medication designed to be used on a chronic basis for the management of fibromyalgia. We believe TNX-102 SL works by improving sleep quality, which leads to improvement of other symptoms. In previous studies, TNX-102 SL showed broad coverage across the symptoms of fibromyalgia, including chronic widespread pain, fatigue and sleep disturbance.”

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University of Montana receives $12.3M National Institutes of Health contract for work on TB vaccine

By: Keila Szpaller, Daily Montanan

November 24, 2023

A vaccine for tuberculosis exists, but TB is still the 2nd leading infectious killer in the world after Covid-19, according to the World Health Organization. With a $12.3 million contract from the National Institutes of Health, researchers at the University of Montana are hoping to improve the vaccine for TB and positively influence global health.

Research associate Alexander Riffey works with the University of Montana’s Center for Translational Medicine, which is working on a tuberculosis vaccine. (UM photo by Tommy Martino)

Last month, the Missoula flagship announced UM and its research partners were awarded a five-year contract to develop a new “adjuvant” to be used with the TB vaccine. Adjuvants are substances that boost the effectiveness of vaccines, and UM’s Center for Translational Medicine has a couple of decades’ worth of work on those substances.

“This funding represents tremendous support for our continuous research efforts in advancing safe and efficient adjuvants and formulation strategies for further development of vaccine candidates against TB,” said Walid Abdelwahab, a co-principal investigator on the project, in a statement. “This contract is a strong endorsement of our exceptional vaccine research team at UM.”

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US Senate confirms Monica Bertagnolli as NIH director

By Ahmed Aboulenein

November 7, 2023

The U.S. Senate on Tuesday voted to confirm President Joe Biden's pick to run the National Institutes of Health (NIH), Dr. Monica Bertagnolli, filling the director spot at the country's top medical research agency after a vacancy of almost two years. Bertagnolli, a cancer surgeon, was approved by a bipartisan 62 to 26 vote. The NIH had been without a director since December 2021, when former director Francis Collins retired, ending a 12-year reign.

"Dr. Bertagnolli will use her new role to advance our nation's understanding of disease and ensure that the groundbreaking research that NIH conducts will yield innovative and life-saving treatments," U.S. Health and Human Services (HHS) Secretary Xavier Becerra said in a statement. Becerra thanked Acting Director Dr. Lawrence Tabak for his leadership of the agency during the vacancy. Since October of last year, Bertagnolli has been leading the National Cancer Institute, the largest component of the NIH. She was previously a surgical oncology professor at Harvard and a surgeon at Brigham and Women's Hospital in Boston.

She becomes the second woman to serve as a permanent director of the NIH, part of HHS with a budget of about $45 billion in 2022. Bertagnolli's appointment had been held up for months after Biden nominated her in May by Senator Bernie Sanders, who sought assurances she would take enough steps to lower drug prices through restoring the agency's "reasonable pricing" clause.

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Industry Leader and Globally Recognized Patient Advocate John F. Crowley Appointed to Lead BIO as President & CEO

Biotech entrepreneur, company founder, tireless patient advocate, and U.S. Navy combat veteran will guide the life science industry in its mission to feed, fuel and heal the world

Press Release

December 5, 2023

The Biotechnology Innovation Organization (BIO) is proud to announce that industry leader and military veteran John F. Crowley will be its new President and CEO, effective March 4. He will replace Rachel King, a longtime BIO board member and industry trailblazer who has served as BIO’s CEO on an interim basis for the past year.

Crowley is best known for his role as an entrepreneur in the biotechnology industry following the 1998 diagnosis of his two youngest children with Pompe disease, a rare and often fatal neuromuscular disorder. His children’s diagnosis inspired him to co-found a biotech company to develop a treatment that he credits with ultimately saving his children’s lives. The Crowley family journey was depicted in the major motion picture “Extraordinary Measures” starring Harrison Ford, Brendan Fraser, and Keri Russell. In 2005, Crowley went on to help found Amicus Therapeutics, a now 500+ person global biotechnology company, where he served as Chairman and CEO from 2005-2022 and is presently the company’s Executive Chairman. He will remain in that role until he transitions to BIO.

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Montana BioScience Alliance- Annual Meeting

At the annual meeting of the Montana BioScience Alliance, we were joined by three new members, Monica Serban, Director of the Biotechnology Center at the University of Montana, Kole Mickolio, CEO TitinKm Biomedical, Bozeman, and Blake Wiedenheft, Professor, Department of Microbiology and Cell Biology, Montana State University.  Elected to the Executive Board were: Cynthia Tsai, President, Ron Zook, Vice President. Corbin Schwanke, Secretary and Carol Beam, Treasurer. We are looking forward to the New Year.  

High School Students Engage in Career Day at MSU Billings

Billings Career Center

October 28, 2023

Huge thank you to the Montana BioScience Alliance for organizing over 60 healthcare professionals to come in and work with our students at their Careers in Healthcare Student Summit. These experts guided our students through a myriad of career pathways, on the job training, certification options, and degree programs available right here in Billings. Over 100 area students also received invaluable insights into resume building and the intricacies and requirements for healthcare jobs. The event was a collaborative and comprehensive one-stop-shop, uniting organizations and universities under one roof to ignite students' interest and empower them with the tools they need for success in the healthcare sector.

We have the absolute best community partnerships here in Billings- thank you to the MT BioScience Alliance for spearheading and bringing all these people together!

Bioscience Workforce Trends in Montana

Thursday, January 4, 2024, at 11 am via Zoom

What: Free webinar for industry partners, workforce development professionals, educators, and bioscience champions, co-hosted by the Montana Bioscience Cluster Initiative and the Montana High Tech Business Alliance.

When: 11 am to 12 pm on Thursday, January 4, 2024,

Where: Virtual via Zoom (Link to participate and a recording will be emailed to all registered event attendees.) 

In the last five years, Montana's bioscience sector has grown rapidly as researchers and companies accelerated innovation in response to industry changes and COVID-19. This virtual event will offer insights and strategies based on the Montana Bioscience Cluster Initiative’s half-decade helping leaders across Montana navigate evolving workforce needs. 

BIO One-on-One Partnering™ with

On-Site Meeting Space at JPM Week

BIO One-on-One Partnering™ is returning to San Francisco for 2024 J.P. Morgan Healthcare Conference week, and we've reserved 40% more space at the San Francisco Marriott Marquis for in-person meetings (available on a first-come-first-served basis for meetings scheduled through the Partnering system on January 8-11.).

By pre-registering for BIO One-on-One Partnering @JPM Week, you'll be able to use our proprietary system to easily identify potential partners and investors no matter where you meet: either in-person or virtually.



Learn more, Click Here!

*Registration Starts December 20th

Learn More, Click Here!

The PHS 2023-2 omnibus solicitations of the NIH, CDC, and FDA for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grant applications have been released. The first application due date is January 5, 2024, so start preparing your application today. As usual, there are four Omnibus Solicitations:

• PA-23-230: PHS 2023-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

• PA-23-231: PHS 2023-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)

• PA-23-232: PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

• PA-23-233: PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)

Please note: The SBIR and STTR Extension Act of 2022 (the Act), signed into law by President Biden on September 30, 2022, reauthorized the SBIR program, the STTR program, and related pilot programs through September 30, 2025.

The Act includes major changes to the SBIR and STTR programs, including:

• increased minimum performance standards (refer to NOT-OD-23-092),
• Pre- and Post- award foreign disclosure requirements (refer to NOT-OD-23-139, view the required form)

Additionally, peer review criteria have changed. As these are significant changes, applicants are urged to read the solicitations in full.

Questions? Contact SEEDinfo@nih.gov.

2024 FAST Micro-Grants are here!

The Montana Innovation Partnership (MTIP) powered by MSU TechLink Center will utilize some of our 2024 FAST funds to provide financial assistance to Montana small businesses that are actively preparing SBIR/STTR proposals in the federal fiscal year 2024.

The costs to apply for an SBIR/STTR grant or contract can be considerable. Financial assistance for early-stage companies increases their participation in the SBIR program and the quality of their proposals.

MTIP will award six FAST Microgrants to eligible SBIR/STTR applicants of up to $2,000 per year. Prospective SBIR/STTR applicants may apply to MTIP to receive Microgrants to attend conferences, travel to speak with agencies or commercialization partners, to acquire consulting services from an approved service provider for assistance with preparation of Phase I or Phase II proposals, to develop supporting project data, and to undertake other activities directly related to their SBIR/STTR proposal.

For more information and to access the application

Click Here!

Open Positions:



-Product and Applications Engineer

-Mechanical Engineer

-Machine Operator I - Assembly & Packaging

-Lead Machine Operator (A&P)

-Customer Support Representative

-Automation and Controls Engineer

-Senior Sales Manager North America - Life Sciences

-Shipping Assistant I

-Customer Support Representative

To find out more about the current open positions and about Mesa Labs, Click Here!

Careers at FYR Diagnostics

FYR Diagnostics is a fast growing Missoula, MT-based biotechnology company developing a powerful portfolio of PCR-focused solutions. FYR Diagnostics’ mission is to commercialize novel detection technologies to help eliminate human suffering by better diagnosing human disease states and to eliminate vast inefficiencies in the agricultural industry.

Those who work with FYR Diagnostics are members of a community that seeks to respect and celebrate all the qualities that make each of us unique. Each of us is empowered to be ourselves within this community, which cultivates and promotes equity, diversity, and inclusion at all levels. FYR Diagnostics is proud to be an Equal Opportunity Workplace and Affirmative Action Employer.

To find out more about the current open positions, Click Here!

Two Bear Capital provides a job board with the different job openings from

the following companies:

-Abilita Bio

-CIQ

-Elisity

-FYR Diagnostics

-Graphiant

-Inimmune

-Novoron Bioscience

-pulseData

-Selector AI

-TileDB

For Open positions with Companies you'll love to work for, Click Here!

Work for a great company in beautiful Bozeman, MT

At Golden Helix, we are committed to accelerating ground-breaking research in genetics, drug discovery and predictive analytics, to our purpose of dramatically improving human health, our great culture, personal development, and strong values.

We are always seeking self-motivated individuals who strive for excellence and have the drive to help us on our journey. We offer competitive wages, benefits and the opportunity to live in one of the most beautiful areas in the world.

Open Positions:

-Area Sales Director

-Director of Renewal Sales

-Finance Manager

-Operations Coordinator

General Employment Inquiries

Interested in a position that we're not actively hiring? Submit your resume for our files! We will archive your information and if a position becomes available that matches your qualifications, we'll contact you.

Click here to apply!

Open Solicitations From Techlink and MTIP

Dates are subject to change. Please refer to each agency site for up-to-date information.

• NIH Targeted funding announcements have varying release and due dates. Find a list of currently open program announcements and requests for applications here.

Links to all participating agencies' SBIR home pages are available here.

Reach out today for no-cost consulting and proposal reviews from one of MTIP's SBIR

experts.

Montana SBIR/STTR Matching Funds Program

What do you do after you have received Stage 1 SBIR/STTR matching funds from the

Montana Department of Commerce, have satisfactorily completed your Phase I work, the

Phase I final report has been accepted by the Federal SBIR/STTR agency, and you have

submitted your SBIR or STTR Phase II proposal?

You submit your Stage 2 application to the Montana SBIR/STTR Matching Funds

Program. You do not have to receive notification of a Phase II award before submitting this

application. For more information, Click Here!

Questions? Feel free to contact Ann at ann.peterson@montana.edu or

Annmarie Robinson with the Department of Commerce at arobinson3@mt.gov.

How would you like to have more free time to focus on innovating and growing your business?

Are you ready to clear your plate of time-consuming daily HR tasks — such as payroll, benefits, talent, and compliance? Right now's the perfect time to see if ADP’s PEO is the right move for you, too.

What is ADP TotalSource?

• Endorsed by BIO for life science companies of any size.
• Full-service PEO (professional employer organization) partner with coverage in all 50 states
• Partner to help you attract and retain top talent more easily with access to ADP Recruiters, HR advisors and best-in-class benefits.
• Industry-leading PEO, giving you confidence that ADP does it the right way.

As an IRS certified and ESAC accredited PEO, ADP meets the highest standards for financial responsibility, ethical business conduct, and regulatory compliance.

Now is the time to start the process if you want to make a change for 2024.

UPS Healthcare brings reliability, scalability and security to life science companies every day. Its portfolio of end-to-end services is well-suited to meet today's complex logistics demands for the pharmaceutical, medical device, and laboratory diagnostic industries. Learn exactly how from UPS Healthcare.

Through Montana BioScience Alliance’s partnership with UPS Healthcare, you get access to exclusive rates on a full suite of UPS® services. And, after recent renegotiations, the savings have gotten even better. While the same popular shipping services, like UPS Next Day Air®, and UPS Worldwide Express SM, remain at reduced rates, the price band range to qualify for discounts is narrower. For example, a company that spends $1,500 to $4,999.99 weekly for UPS Next Day Air® shipping now receives a 60% discount rather than a 50-55% discount under the previous arrangement.

As a Montana BioScience Alliance member, be confident that your critical healthcare shipments will be delivered timely and with care by a quality-focused and patient-driven organization.

Montana BioScience Alliance Members Save Up To:

· 74% on UPS Next Day Air®

· 59% on UPS 2nd Day Air® & UPS 3 Day Select Services®

· 51% on UPS Ground® Commercial Services

· 68% on UPS Worldwide International Services