AZBIO 2024-2025

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ARIZONA BIOINDUSTRY ASSOCIATION

AZBio chairman’s message

Welcome to the 2024 AZBio magazine, highlighting Arizona’s life sciences community. In the pages that follow, we give you a front-row seat to the remarkable progress and vibrant future of the bioindustry in Arizona. Our state has emerged as a powerhouse of innovation and collaboration, driven by the collective efforts of industry leaders, academic institutions, government agencies, and community organizations. Together, we are building a thriving ecosystem that is making a significant impact on global health and our state’s economic development. We are excited to share this with you.

Inside, we tell the story of this year’s AZBio awards winners and their incredible contributions to our community. We also spotlight the remarkable winners of the AZBio awards over our 20-year history, highlighting the important contributions of companies, leaders, and researchers who have grown the life sciences in Arizona. And we feature health innovations and innovators, focusing on the educators, researchers, healthcare professionals, business leaders, and community leaders who champion the discovery, development, and delivery of treatments and cures.

The Arizona Bioindustry Association (AZBio) plays a pivotal role in this growth. As the state’s leading advocate for the life

sciences, AZBio is dedicated to advancing the bioindustry through advocacy, education, and collaboration. Our mission is to support the development of lifesaving and life-enhancing innovations by providing our members with the resources, connections, and opportunities they need to succeed.

Our industry is not only advancing scientific discovery but also driving substantial job growth. Over the past

decade, we have witnessed a significant increase in employment opportunities within our sector. This trend is expected to continue as we attract more companies and investment to our state. The diverse range of careers available, from research and development to manufacturing and clinical trials, ensures that Arizonans have access to fulfilling and well-paying jobs.

We are proud of how far our life science community has come and are inspired by the future. We eagerly look forward to the Flinn Foundation’s renewal of the Arizona Bioscience Roadmap, set to be released in mid-2025. This roadmap will be a crucial guide for our future efforts, helping us to build on our successes and navigate new challenges.

Finally, I would like to extend my heartfelt congratulations to this year’s AZBio awards winners. Your achievements exemplify the excellence and innovation that define our community. Your dedication and hard work inspire us all, and we are proud to celebrate your success.

Thank you for your dedication and commitment to the Arizona bioindustry. Together, we are making a difference in the lives of the patients we all serve. We hope you enjoy reading more about our bioindustry.

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CHAMPIONING HEALTH INNOVATION

For more than two decades, the Arizona Bioindustry Association, Inc. (AZBio), has been championing health innovation and health innovators in Arizona. AZBio is more than a nonprofit organization, it is a community of over 300 organizations that together employ over 350,000 Arizonans. AZBio’s community includes educators, researchers, health innovators, healthcare professionals, business leaders, and community leaders who champion the discovery, development, and delivery of treatments and cures.

Health innovations are being created at a faster pace than ever before. But so much more is needed. The more we learn about disease, the more complex the solutions

get. It has been reported that there are over 20,000 health disorders and many of them have no effective treatments. This is especially problematic in the case of rare diseases where over 90% have no effective treatment. The FDA defines a rare disease as a disease that affects fewer than 200,000 people in the United States. It is estimated that 1 in 10 Americans or around 30 million people in the U.S. have a rare disease.

Cures are extremely rare. A cure occurs when a medical condition is completely gone and will never come back. The first hepatitis C treatment was approved in 1991, but it had a cure rate of only about 6%. Today, treatments have improved dramatically, with today’s treatments

having a success rate of more than 95%.

The CDC estimates that 2.7 million people in the U.S. have chronic hepatitis C. This is the only chronic viral disease that can be completely cured. Hepatitis B does not have a cure. Instead, health professionals recommend a vaccine to help prevent the disease from occurring.

Tuberculosis (TB), contagious bacterial infection that can affect the lungs and other parts of the body, is an example of a bacterial based disease that can be cured permanently if treated properly with antibiotics.

SMA, Spinal Muscular Atrophy, is a rare disease caused by genetic mutations in the SMN1 gene. Zolgensma is a gene therapy that can stop the progression of SMA. It

works by replacing a nonworking or missing SMN1 gene with a normal one. It is not considered a cure because it can’t reverse damage caused by SMA before treatment.

Diabetes is a metabolic disease that disrupts the body’s ability to convert food into energy. Insulin was discovered in 1921 and was first mass produced by Eli Lilly in 1923 with Novo Nordisk following soon after. In the last 100 years, we’ve made great strides forward in our ability to treat type 1 and type 2 diabetes, facilitated by an improved understanding of the pathophysiology of the disease and improvements in insulin formulation and delivery. We have yet to develop a cure or a treatment that can stop or prevent the disease.

Eradicating a disease means permanently reducing the number of cases to zero through deliberate measures, such as vaccines. Once a disease has been eradicated, intervention measures are no longer needed. The world has only eradicated two diseases. Smallpox was the first disease to be declared eradicated worldwide in 1980. Rinderpest, a disease that affected cattle, was declared eradicated in 2011.

Eliminating a disease means there are no instances spreading within the

country and new cases are only found when someone contracts the disease abroad and returns to the country. Measles was officially eliminated from the United States in 2000. Measles is highly contagious and still occurs in other parts of the world. Travelers have brought measles back to the U.S. resulting in outbreaks. This year (as of July 25, 2024), a total of 188 measles cases were reported across the country including in Arizona. For this reason, it is still important that all people who can be vaccinated for the measles do so.

The most common disease that has no cure

Colds account for more visits to the doctor in the United States than any other condition. In most cases, a cold may last for about a week, but some colds last longer, especially in children, the elderly and those in poor health. These minor infections of the nose and throat are not one disease. Colds are highly contagious and can be caused by more than 200 different viruses. There is no cure for the common cold. Medicines may help alleviate symptoms and promote healing, but it is your immune system that defeats the infection and allows you to recover.

Health innovations

Treatments include medicines, medical devices, procedures, medical interventions, and therapies designed to improve your health and quality of life. The Food & Drug Administration (FDA) has approved over 20,000 drugs and biologic medicines as well as over 6,500 medical devices. FDA approval designates that these treatments are safe and effective. Nutraceuticals including vitamins, minerals, amino acids, herbs, and botanicals are not FDA approved or evaluated for effectiveness by FDA. Federal law requires manufacturers to ensure nutraceuticals are safe before they are marketed. If it is determined a nutraceutical product is unsafe after it is marketed, the FDA can act.

Medicines, including pharmaceutical drugs, biologics, and vaccines are used to diagnose, cure, treat, or prevent disease. Here in Arizona, Bristol Myers Squibb manufactures Abraxane® a chemotherapy that is FDA approved for the treatment of advanced breast cancer, non-small cell lung cancer, and pancreas cancer. Primus Pharmaceuticals offers four prescription products including a topical product for the treatment of atopic dermatitis and food grade pharmaceutical products that help patients with conditions including osteopenia and osteoporosis, chronic venous disease, and the metabolic effects of methotrexate therapy. Arizona’s drug development pipeline includes AZBio Members Aqualung Therapeutics, Avery Therapeutics, Micro Vascular Therapeutics, NuvOx Therapeutics, PriZm Therapeutics, SLAM Bio, Sonoran Biosciences, and more.

Vaccines have saved an estimated 154 million lives in the past 50 years based on a 2024 report published in the Lancet. The study looked at 14 different diseases. Children under 5 years of age have benefited most. These medicines protect the body’s immune system against specific diseases, such as measles, influenza, or whooping cough. Vaccines can be administered by injection, orally, or as a

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nasal spray. New work in vaccines includes the rapid development of vaccines used during the COVID-19 pandemic. Other vaccines like the Shingles vaccines that help protect against painful viral skin infections, the new RSV vaccine that is recommended for pregnant women, babies and seniors, and HPV vaccines that protect against a viral infection that is linked to 6 different cancers.

Here in Arizona, extensive vaccine research has been done at the Biodesign Institute at ASU, at TGen, and at University of Arizona Health Sciences.

AZBio Members CSL, Johnson & Johnson, Merck, and Novartis are some of the leading vaccine producers in the world. Calviri, the 2024 Arizona Bioscience Company of the Year, has recently completed the largest cancer vaccine trial ever completed with dogs and is working on both diagnostics and a vaccine that may help prevent cancers in our fourlegged friends and save people’s lives in the future.

Regenerative medicine includes gene therapies, cell therapies, and tissueengineered products intended to augment, repair, replace, or regenerate organs, tissues, cells, genes, and metabolic processes in the body.

Regenerative medicine aims to alter the current practice of medicine by treating the root causes of disease and disorders.

To date, the FDA has authorized 36 cell and gene therapies. More than 15 new cell and gene therapies are predicted to come to market in 2024, and by 2030, 54 approved cell and gene therapies are expected in the FDA pipeline.

MEETING ON THE MESA

What: The Meeting on the Mesa will bring together leaders in the exciting field of regenerative medicine, which includes gene therapies, cell therapies, and tissue-engineered products.

When: October 7-9, 2024, in Phoenix.

Learn more: meetingonthemesa.com

Here in Arizona, the Meeting on the Mesa will bring leaders in this exciting field to Arizona on October 7-9, 2024.

AZBio Members Amgen, Bristol Myers Squibb, City of Hope, CSL Behring, Gilead, Mayo Clinic, Novartis, Roche, Sarepta Therapeutics, Translational Genomics Research Institute (TGen), Vertex Pharmaceuticals have all been involved in this exciting innovation area.

Medical technology (MedTech or medical devices)

Medical technology includes items, instruments, apparatuses, or machines that are used in the prevention, diagnosis or treatment of illness or disease, or for detecting, measuring, restoring, correcting, or modifying the structure or function of the body for some health purpose. This broad category ranges from simple bandages to extraordinarily complex devices.

Here in Arizona, medical device manufacturing is one of our largest employment sectors and includes Anuncia Medical, Becton Dickinson Peripheral Interventions, GE Healthcare, Medtronic, Regenesis Medical, Stryker, SynCardia Systems, W.L. Gore and more.

Diagnostics are tests used by health professionals to diagnose disease or monitor disease states. Other tests are screening tests that detect irregularities or potential issues, they may not provide answers. Colorectal screening can take the form of colonoscopies, stool tests, and blood tests. Colorectal cancer is the second leading cancer killer in the U.S.

MalaCards database

The MalaCards database includes:

• 22,960 Total disorders

Global categories include:

• 3,932 cancer diseases

• 9,390 genetic diseases

• 2,821 metabolic diseases

Source: malacards.org (March 2024)

among cancers that affect both men and women. In 2024, there will be an estimated 152,810 new cases of colorectal cancer diagnosed in the U.S. and 53,010 people will die from the disease. Colorectal cancer is treatable in about 90% of people when caught early. Based on medical literature, the majority of screenings have normal results. If something is not normal, further diagnostic tests are performed to determine why. The FDA classifies most diagnostics as medical technologies.

Here in Arizona, we are a diagnostics powerhouse. Sonora Quest Laboratories is one of the nation’s largest integrated laboratory systems and performs more than 97 million diagnostic tests per year. TGen, the Translational Genomics Research Institute, is a world leader in exploring new ways to innovate with omics data and Arizona health innovators Accelerate Diagnostics, Inc., Castle Biosciences, CND Life Sciences, Exact Sciences, and Roche Tissue Diagnostics are ensuring that medical professionals have the information they need to diagnose and treat disease.

Championing health innovation

Arizona is the place where health innovators are developing and delivering innovations that improve the lives of people in Arizona, across the country, and around the world.

On September 18, 2024, our community will come together at the 20th annual AZBio Awards to celebrate the people and the companies that make our community so special.

• 15,278 Gene-related Disorders

• 5,883 fetal diseases

• 1,023 infectious diseases

• 14,942 rare diseases

NEVER ENOUGH

Each day we have with the people we love is precious, and there are never enough.

When someone we love lives with disease, we do what we can to help; and feel like it is never enough.

Every time as researchers, innovators, and healthcare teams we are not able to conquer a disease in time, we know that for all that we do, until we succeed, it is never enough.

So we keep loving, keep helping, keep working to find answers. For when we do, someday, it will be enough.

Thank you to all of the family members, friends, caregivers, researchers, innovators, investors, philanthropists, healthcare teams, and, most of all, to the patients who work together to get us to someday.

20 years of AZBio Awards

The 20th annual AZBio Awards ceremony on September 18, 2024, shines a spotlight on Arizona life science companies and leaders. Here is a highlight from each year leading up to this milestone.

2005: Nanobiomics is the Bioscience Company of the Year. The company merged with the Molecular Profiling Institute which was acquired by Caris Diagnostics in 2008. Today Caris Life Sciences provides cancer patients and oncologists with reliable, high-quality, comprehensive molecular information to deliver on the promise of precision medicine from its our state-of-the-art laboratory and R&D facilities located in Phoenix, Arizona.

2006: Ventana Medical Systems, Inc. is Medical Device Company of the Year. In 2008, Roche acquired Ventana for $3.4 billion. Today Roche Tissue Diagnostics is the largest life science employer in Southern Arizona and has revolutionized cancer diagnostics worldwide through state-of-the-art testing automation. The company offers more than 250 cancer tests and associated instruments and is the leading global supplier of cancer diagnostic systems to the pathology market.

2007: Dr. Jeffrey Trent is honored as Bioscience Executive of the Year for his work

creating and leading the Translational Genomics Research Institute (TGen). Today, TGen conducts groundbreaking research with life-changing results. TGen is part of City of Hope, a world-renowned independent research and treatment center for cancer, diabetes, and other lifethreatening diseases.

2008: Michael Cusanovich, PhD, is honored with the Jon W. McGarity Leadership Award for his work in bringing together Arizona’s statewide bioscience cluster. Dr. Cusanovich died unexpectedly on April 12, 2010. Today, AZBio honors exemplary educators each year with the Michael A. Cusanovich Bioscience Educator of the Year award.

2009: Bruce Rittman, PhD, is honored with the Award for Research Excellence. Dr. Rittmann is Director, Center for Environmental Biotechnology at the ASU Biodesign Institute and develops microbiological systems that capture renewable resources and minimize environmental pollution.

2010: Abraxis BioScience is Bioscience Company of the Year. Abraxis created the cancer treatment Abraxane®. In June of 2010, Abraxis was acquired by Celgene for $2.9 billion. Celgene was later acquired by Bristol Myers Squibb (BMS) in 2019. Abraxane is manufactured at the BMS Phoenix facility and is used by oncologists to help patients with advanced breast cancer, pancreatic cancer, or non-small cell lung cancer.

2011: SynCardia Systems, Inc. is named the Arizona Bioscience Company of the Year. The SynCardia Total Artificial Heart is the first and only commercially available FDA and Health Canada approved total artificial heart. The SynCardia Total Artificial Heart has been implanted in over 2,000 patients across 20 countries and has provided 293,997 days of life to patients with heart failure.

2012: Dr. Jennifer Kahlet Barton of the University of Arizona is named the Michael A. Cusanovich Educator of the Year. Today, Dr. Barton is Director of the BIO5 Institute at U of A where hundreds

of researchers are solving the world’s most complex biology-based challenges.

2013: W.L. Gore and Associates is Bioscience Company of the Year. Today, Gore continues its commitment to improve lives through innovative medical products. In Arizona, Gore manufactures vascular grafts, endovascular and interventional devices, and catheters used by health care professionals to improve the lives of patients worldwide, resulting in 55 million medical devices implanted to date. Since 2013, Gore’s Associate population in Arizona has grown from 2,500 to near 4,000 Associates.

2014: Charles Arntzen, PhD, of the Biodesign Institute at ASU is the Arizona Bioscience Researcher of the Year. His research received global attention when it was applied to a treatment used to treat U.S. aid workers infected with Ebola. “Charlie Arntzen has been one of the most important faculty members in the history of this university. He’s a person who can think, connect, drive, create and link ... do all of that in the spirit of a scientist in either a corporate or university setting,” according to ASU President Michael Crow. Today, Dr. Arntzen is enjoying a welldeserved retirement.

2015: Gordon Steere, who led the Medtronic Tempe Campus from 19972008 is honored with the AZBio Pioneer Award for Lifetime Achievement. Today over 1,000 Medtronic employees in Arizona design, develop, manufacture and test microelectronics solutions used in Medtronic implantable devices, such as cardiac pacemakers and defibrillators, devices that help patients with diabetes manage their insulin levels safely and effectively, spinal cord stimulators for pain

management and deep brain stimulators that address movement disorders.

2016: Stephen Albert Johnston, PhD is the Arizona Bioscience Researcher of the Year for his groundbreaking work in diagnostics and vaccine development. Today, Johnston leads Calviri, the 2024 Arizona Bioscience Company of the Year.

2017: Marvin J. Slepian, MD of the U of A is honored with the AZBio Pioneer Award for Lifetime Achievement. He continues to work to develop novel solutions to the broad range of continuously emerging unsolved problems and unmet needs in health care, well care and overall individual well-being, as Director of the Arizona Center for Accelerated Biomedical Innovation (ACABI).

2018: Heather Bimonte-Nelson, PhD, of ASU is the Michael A. Cusanovich Bioscience Educator of the Year. Today, Dr. Bimonte Nelson is an ASU President’s Professor in the Department of Psychology. An expert in cognitive function and aging, especially as it relates to menopause and hormones, she directs the Behavioral Neuroscience of Memory and Aging Lab, which investigates the roles that sex, hormones and brain chemistry play in brain function and cognition.

2019: Regenesis Biomedical, Inc. is the Arizona Bioscience Company of the Year. Regenesis is a device company dedicated to improving human welfare through the research, design, manufacture, and sale of energy-based medical products and services that alleviate pain to improve quality of life. In 2023 the FDA cleared Regenesis Medical’s Reprieve system to

help patients living with Diabetic Foot. The product is currently cleared to treat the pain associated with diabetic neuropathy.

2020 : Joshua LaBaer, MD, PhD, is named the Jon W. McGarity Bioscience Leader of the Year. He continues to lead the Biodesign Institute at Arizona State University and its team of researchers from a variety of disciplines who come together to tackle some of humanity’s most complex challenges. Scientists at Biodesign are undertaking research in over 300 active research projects.

2021: BioLab Sciences is the Arizona Bioscience Company of the Year. In 2024, BioLab celebrated its 6th anniversary and cut the ribbon on its new expanded manufacturing facility in Mesa, Arizona.

2022: Caris Life Sciences is the Arizona Bioscience Company of the Year. Caris provides cancer patients and oncologists with reliable, high-quality, comprehensive molecular information to deliver on the promise of precision medicine. Its state-ofthe-art laboratory and R&D facilities are primarily located in Phoenix, Arizona.

2023: John N. Galgiani, MD, director of the Valley Fever Center for Excellence at the University of Arizona is honored with the AZBio Pioneer Award for Lifetime Achievement. Since Arizona is the epicenter of this disease, it is quite appropriate that Arizona leads in solving this problem.

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2024

AZBio Pioneer Award for Lifetime Achievement: Sidney Hecht, PhD

Sidney Hecht is a key figure who has helped bridge the gap between chemistry and biology. His pioneering work has inspired new ways of studying and improving human wellbeing by exploring molecules and their essential roles in health and disease.

Among his many notable achievements is the development of Hycamtin, a drug used to treat cancers such as small cell lung cancer, cervical cancer, and metastatic ovarian cancer. An earlier approach, using a natural antibiotic, showed promise in lab studies but failed in clinical trials. After exploring the chemical and biological properties of the earlier drug, Hecht and his research team developed a more effective version that has since become a key option for treatment, used in cases where other therapies have been ineffective.

Hecht and his team also conducted important research on bleomycin, a drug used to treat squamous cell carcinoma, Hodgkin’s lymphoma and testicular cancer. Their work improves the clinical ability to target tumors, making bleomycin one of the most well-understood and valuable anticancer drugs in use today.

As director of the Biodesign Center for Bioenergetics at Arizona State University, Hecht currently focuses on disorders that affect mitochondria. Contained in nearly every human cell, mitochondria provide most of the energy our bodies use and

A LIFETIME OF IMPROVING HUMAN HEALTH

play a key role in metabolism, growth and muscle function. Mitochondrial diseases are usually degenerative and affect children and young adults.

Early in his career, Hecht pioneered a technique that allowed scientists to create proteins with unique structures and properties, opening the door to new research and potential treatments for rare disorders. Today, his team continues to explore how biological mechanisms can be harnessed to develop innovative therapies.

Early in his career, Hecht developed a technique that allowed scientists to create proteins with unique structures and properties, opening the door to new research and potential treatments for rare disorders. Today, his center continues to study biological mechanisms that can lead to new research strategies and potential new treatments. For example, he and his team are studying special RNAs that can alter proteins, which may help correct defects linked to rare disorders.

Hecht is dedicated to translating scientific discoveries into practical applications. He is named an inventor

on 45 U.S. patents and co-founded a company, Edison Pharmaceuticals, to advance treatments for inherited mitochondrial disorders. A compound identified by the company has conducted advanced clinical trials as a treatment for Friedreich’s ataxia, a rare, inherited disorder that causes progressive damage to the nervous system, often beginning in childhood. A second set of compounds developed at ASU has garnered interest from another pharmaceutical company for treatment of neurodegenerative diseases.

Hecht joined ASU from the University of Virginia, where he was a professor of chemistry and biology. From 1981 to 1987, he also held leadership positions in research and development for Smith Kline and French Laboratories. Prior to his 28 years at the University of Virginia, he was a faculty member at MIT.

Throughout his career, he has published more than 480 papers, delivered more than 400 invited lectures, and taught and mentored countless undergraduate and graduate students.

LIFETIME OF LEADERSHIP:

Arizona’s life science community is honoring Professor Sidney Hecht, director of the Biodesign Center for Bioenergetics at Arizona State University with the AZBio Pioneer Award for Lifetime Achievement at the 20th annual AZBio Awards on September 18, 2024, at the Phoenix Convention Center. (Image Courtesy ASU Biodesign Institute)

2024 Arizona Bioscience Company of the Year: Calviri

A COMMITMENT TO ENDING CANCER

According to the National Cancer Institute, 2,001,140 new cases of cancer are estimated to be diagnosed in the United States in 2024, which is about 5,480 new cases per day. An estimated 611,720 people are also expected to die from cancer in 2024.

The American Association for Cancer Research projects that annual cancer care costs in the US will exceed $245 billion by 2030.

The Veterinary Cancer Society reports that cancer is the leading cause of death in 47% of dogs, especially dogs over age ten. Dogs get cancer at about the same rate as humans.

Globally, it is estimated that the total economic cost of cancer will reach over $25 trillion by 2030.

These numbers are scary, but they cannot compare to sitting in a doctor’s office and hearing “You have cancer.”

Today, we treat cancer and measure success in 5-year survival rates. Cancer treatment can be brutal and often financially toxic. Even then, we are not always successful in halting the progression of this dreadful disease. Imagine, if in our lifetime, we could say, “People used to get cancer.”

Calviri is a small, Phoenix, Arizona

based company with a big mission. Calviri’s team is on a mission to end cancer worldwide — with affordable products. The company is developing a diagnostic for the early detection of cancer in dogs and people, as well as off the shelf therapeutic and preventative cancer vaccines. Calviri is a spinout of Arizona State University and headquartered in the Phoenix Bioscience Core.

Calviri announced the successful conclusion of its Vaccine Against Canine Cancer Study (VACCS) on May 4, 2024. This five-year clinical trial investigated a novel preventative cancer vaccine in dogs. This multi-center, double-blind, placebo-controlled study, the largest of its kind in veterinary oncology, represents a significant milestone in the fight against canine cancer.

For many years, attempts at developing cancer vaccines have been unsuccessful. However, the realization of the importance of neoantigens for generating immune responses against tumors has led to recent reports of successful vaccines in humans. Neoantigens are irregular peptides from mutations in tumor DNA. Unfortunately, these mutations are unique to each patient,

requiring personal vaccines.

Calviri’s VACCS trial marks a paradigm shift by leveraging what we now know are shared neoantigens. Stephen Albert Johnston, CEO of Calviri and former Professor at Arizona State University, discovered these unique protein fragments that arise from errors during tumor RNA processing, and that they are present across multiple cancer types. The VACCS vaccine consisted of 31 of these shared neoantigens, allowing for a broadspectrum approach to cancer prevention. This strategy has the potential to revolutionize canine cancer prevention by offering a single vaccine to protect against a wide range of cancers and may provide critical proof-of-concept to initiate similar efforts for human cancer.

The VACCS trial was made possible thanks to grant funding from Open Philanthropy and stands as a significant advancement in the field of canine cancer prevention. This trial has the potential to pave the way for a future where canine cancer is not a constant threat, but a preventable disease.

“The VACCs team has done an amazing job” says Heather Youngs, senior program officer at Open Philanthropy. “We are so pleased with the progress on this trial and the potential of this technology to save many animal (and potentially human) lives in the future.”

For its team’s commitment to ending cancer by developing a diagnostic for the early detection of cancer in dogs and people, as well as off the shelf therapeutic and preventative cancer vaccines, Calviri is being honored as the 2024 Arizona Bioscience Company of the Year.

Learn more about this exciting Arizonabased company at calviri.com.

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2024 Jon W. McGarity Arizona Bioscience Leader of the Year: Kristen Oelschlager

IMPACTING THE CARE OF PATIENTS

At the Castle Biosciences lab in Downtown Phoenix, team members use complex science to give patients and their healthcare teams information that helps patients receive the best care possible. Castle’s founding team believed that the traditional methods to determine cancer patients’ prognoses could be improved by harnessing the biology of their tumors. Today, the company is improving health through innovative tests that guide patient care.

In 2008, Kristen Oelschlager and co-founders Derek Maetzold and Toby Juvenal launched an entrepreneurial endeavor, Castle Biosciences, to develop and deliver innovative testing solutions to guide treatment decisions for patients impacted by cancers. With a diverse background spanning more than 15 years in clinical nursing, operations services and research, Oelschlager brings a unique perspective that has been instrumental in the Company’s ongoing growth and success.

“Kristen’s tenacity, thoughtful leadership and passion for people have had an immeasurable influence on Castle’s growth trajectory, our strong workplace culture and the legacy of improved patient care that we are working to build as a company,” says Maetzold, president and chief executive officer of Castle. “It has been an honor to work alongside her for the better part of two decades, and I can think of no person more deserving of this honor.”

Castle Biosciences began operations in 2008 and an early success was the licensing of DecisionDx®-UM, which the

company still offers. The test identifies which patients with uveal melanoma, a rare type of cancer that occurs in the tissues of the eyes, are at low or high risk for disease progression. This information helps patients and their care teams determine a risk-appropriate treatment plan to manage their disease.

Today, Castle’s portfolio consists of additional tests for skin cancers, Barrett’s esophagus and mental health conditions. Additionally, the company has active research and development programs for tests in other diseases with high clinical need, including its test in development to help guide systemic therapy selection for patients with moderate-to-severe atopic dermatitis, psoriasis and related conditions.

Leading the operations of a rapidly growing company while maintaining focus on its mission and workplace culture is not an easy task. Oelschlager and her co-founders have successfully navigated product line expansions, research programs that have resulted in new, best-in-class diagnostic tests,

GROUNDBREAKER:

Castle Biosciences’ Chief Operating Officer Kristen Oelschlager was selected among the Top 25 Women Leaders in Biotechnology by The Healthcare Technology Report. (Provided photo)

an IPO in 2019, three acquisitions, expansion of the company’s facilities in Texas and Pennsylvania, and more than quadrupling the size of the company’s original laboratory in Phoenix.

The validity and utility of Castle’s innovative tests has been demonstrated in more than 140 peer-reviewed publications, and more than 200,000 test reports have been delivered to clinicians since 2008 to guide improved disease management decisions for patients.

“The entirety of Kristen’s professional career has been dedicated to positively impacting the care of patients, first at the bedside as a nurse and now more broadly through her work at Castle Biosciences,” says Joan Koerber-Walker, president and chief executive officer of AZBio. “Kristen’s contributions to the advancement of patient care are helping to re-shape disease management paradigms in Arizona and beyond, and we are pleased to honor her as the 2024 Arizona Bioscience Leader of the Year.”

DecisionDx-UM is a trademark of Castle Biosciences, Inc.

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2024 Arizona Bioscience Researcher of the Year: Nader Sanai, MD

A MISSION TO DEFEAT BRAIN CANCER

Glioblastoma is one of the deadliest, most complex and treatmentresistant cancers. It is currently incurable. Survival rates haven’t risen in decades and a new FDA-approved therapy hasn’t been introduced in as long. Federal funding for brain tumor research lags well behind other cancer research and this margin continues to widen.

Patients are left with few options and dire odds. But there are always exceptions, says Dr. Nader Sanai, the 2024 Arizona Bioscience Researcher of the Year, and he’s committed to making each patient an exception.

To see this mission to completion and find a cure for this devastating disease, Dr. Sanai founded the Ivy Brain Tumor Center at Barrow Neurological Institute. With large-scale funding from the Ben & Catherine Ivy Foundation and the Barrow Neurological Foundation, the Ivy Center was established in 2018. In assembling the world’s largest Phase 0 clinical trials program, the Ivy Center offers state-of-theart clinical trials never attempted in the field of neuro-oncology. As a neurosurgeon and principal investigator, Dr. Sanai oversees these impactful early-phase studies in the operating room and then moves to the lab to determine whether the experimental therapy is having an effect in his patient’s tumor. Promising therapies are accelerated in their development, while

unpromising ones are shut down rapidly.

“Our clinical trials preserve the one commodity all brain cancer patients have in short supply — time,” Dr. Sanai says.

A global stage

The success of the Phase 0 program has prompted acceleration of new drugs to the

“Our clinical trials preserve the one commodity all brain cancer patients have in short supply — time.”
Dr. Sanai

worldwide patient population. In 2024, the Ivy Center partnered with GSK to sponsor the Gliofocus Study, a global, randomized, controlled Phase 3 clinical trial that will enroll 450 patients in over 120 clinical sites across 11 countries. The results of the study will form the basis for potential worldwide approval of a new standardof-care therapy in newly diagnosed glioblastoma patients.

“The pivotal Phase 3 Gliofocus Study represents a crucial step forward to transform outcomes for glioblastoma patients worldwide,” says Dr. Sanai. “At the Ivy Center, we are committed to pioneering new standards of care that redefine possibilities in brain cancer treatment.”

Inspiring the next generation

Having completed over 4,500 brain tumor operations since 2011, Dr. Sanai is one of the country’s busiest brain tumor neurosurgeons. He has authored over 300 peer-reviewed research manuscripts and delivered more than 200 national and international lectures. His groundbreaking work is supported by leading granting agencies, including the NIH and the NCI.

Dr. Sanai leads a dynamic, multidisciplinary team of more than 50 physicians, scientists, nurses and staff from around the world, all driven by an ambition and dedication to changing the face of brain cancer care. As a mentor, he guides aspiring investigators and clinicians, as well as oversees one of the nation’s only neurosurgical oncology fellowships.

Through his relentless pursuit of a cure for brain cancer, Dr. Sanai inspires new generations of clinicians and researchers, united in a mission to change the realities for patients facing the fight of their lives.

Discovering Tomorrow’s Treatments Today

The Ivy Brain Tumor Center at Barrow Neurological Institute is dedicated to finding a cure for glioblastoma and other aggressive brain tumors through a broad portfolio of Phase 0 clinical trials, combining industry-partnered drug development with the nation’s largest operative brain tumor volume.

The Ivy Center’s central strategy is to introduce patients to first-in-class therapies, develop combined-agent strategies that overcome tumor resistance, and validate the effectiveness of promising new regimens through randomized controlled clinical trials. Together, these efforts position the Ivy Center at the forefront of redefining brain tumor treatment and offering new hope to patients.

CONGRATULATIONS TO DR. NADER SANAI, 2024 ARIZONA BIOSCIENCE RESEARCHER OF THE YEAR

ENGAGING AND INSPIRING THE NEXT GENERATION OF HEALTH INNOVATORS

One of the most impactful student programs hosted by the University of Arizona’s BIO5 Institute is the Keeping Youth Engaged in Science (KEYS) research internship. KEYS recruits and attracts the best and the brightest from the state’s many diverse communities to the university for the experience of a lifetime. Through KEYS, interns learn and grow, while gaining the experience, skills, and conviction that will allow them to thrive in a rapidly changing world. KEYS provides many incentives for these promising students to stay in Arizona for college, and beyond.

Kelle Hyland serves as Program Manager, Outreach & Engagement for the BIO5 KEYS Research Internship Program and is being honored as the 2024 Michael A. Cusanovich Bioscience Educator of the Year by AZBio.

Since joining the KEYS program in 2016, Hyland has shown exceptional leadership, expanding the program’s reach and impact, especially during challenging times like the COVID-19 pandemic. Under her guidance, KEYS has grown in diversity and inclusivity, providing invaluable research opportunities to underserved students.

Her innovative approach to education, including transitioning to a virtual format and securing vital funding, has ensured the program’s continuity and success.

KEYS interns not only gain experience in interdisciplinary bioscience, biomedical science, biostatistics, biomedical engineering, data science, or environmental health research, among other STEM areas, but also train in biotechnology skills, science literacy, ethics, and communications that they typically would not learn in the classroom.

To become our leaders of tomorrow, today’s students need determination, curiosity, and a mindset that embraces teamwork, creativity, problem solving, and emotional competence. These are all capabilities reinforced through the KEYS experience.

“Each year, AZBio honors an educator who, as a member of the faculty or administration of an educational institution, demonstrated the greatest leadership, creativity and/or actions to inspire students and encourage them in the biosciences,” shares AZBio president and CEO Joan Koeber-Walker. “On behalf of Arizona’s health innovation community, we congratulate Kelle Hyland for this wellearned recognition.”

“Kelle’s dedication, mentorship, and ability to inspire students to pursue STEM careers makes her truly deserving of this prestigious award,” shares Dr. Jennifer Barton, director of the BIO5 Institute at the University of Arizona.

The next cohort of KEYS student interns will start this valuable learning experience in June of 2025. Applications open in the fall of 2024. You can learn more at keys. arizona.edu.

SETTING THE STAGE: Kelle Hyland serves as program manager, Outreach & Engagement for the BIO5 KEYS Research Internship Program and is the 2024 Michael A. Cusanovich Bioscience Educator of the Year. (Photo courtesy of University of Arizona)

2024 AZBio Fast Lane Honoree: Nectero Medical

TREATING ANEURYSMAL DISEASE

Every year, about 200,000 people in the U.S. are diagnosed with an abdominal aortic aneurysm (AAA), according to the Society for Vascular Surgery. A ruptured AAA is the 15th leading cause of death in the United States, and the 10th leading cause of death in men older than 55. In many cases, having an AAA is usually not a serious health threat, but a ruptured AAA can be life-threatening. When an AAA ruptures, it can cause massive internal bleeding, which is often fatal. Only about 1 in 5 people survive a ruptured AAA.

Nectero Medical is a clinical-stage biotechnology company pioneering novel therapies to treat aneurysmal disease based in Tempe, Arizona.

The company is developing the Nectero EAST® System. This investigational, single-use, endovascular system delivers pentagalloyl glucose (PGG) locally into the aneurysmal wall, where it binds to elastin and collagen to potentially strengthen the aortic vessel wall and possibly reduce further degradation. The procedure is typically performed under conscious sedation and takes less than an hour to complete, leaving no permanent implant behind.

“Each year a select group of Arizona based life science companies are recognized for the progress they are making to develop and deliver health innovations,” says Joan KoerberWalker, president & CEO of the Arizona Bioindustry Association. “Nectero Medical’s journey began here in 2017, and they have made significant progress. We are pleased to recognize the

Nectero Medical team with a 2024 AZBio Fast Lane Award.”

In 2023, the Food and Drug Administration (FDA) granted Fast Track and Breakthrough Therapy designations to the Nectero EAST System for treatment of infrarenal AAAs with a maximum diameter 3.5 – 5.0cm. These designations reflect the FDA’s recognition of a therapy’s potential to treat a serious condition and address an unmet medical need; while affording intensive FDA guidance and support through the development process.

In January of 2024, Nectero Medical completed a $96 million Series D financing round. Financing was led by Norwest Venture Partners, with large investments from Boston Scientific Corporation, BioStar Capital, Cadence Healthcare Ventures, Aphelion Capital and other firms.

“We are honored and excited to be the lead investor in the Series D financing to fund the efforts necessary to bring the Nectero EAST System to market,” says Dr. Zack Scott, General Partner, Norwest Venture Partners. “The Nectero EAST System has the potential to have a profound impact on the hundreds of thousands of patients living with aneurysmal disease and would represent the most significant advancement in the treatment of AAA in over 25 years.”

In January 2024, Nectero Medical initiated a Phase II/III clinical trial (stAAAble) to investigate the safety and efficacy of the Nectero EAST System in patients with infrarenal AAAs, maximum diameter 3.5 – 5.0cm.

Dr. Zack Scott, of Norwest Venture Partners, and Dr. Alan Davis, of BioStar Capital, have joined the Nectero Medical Board of Directors.

“We are pleased to have raised the funds required to complete the necessary work to bring our potentially transformative technology to market,” says Jack Springer, President & CEO, Nectero Medical. “In addition, we are fortunate to add two highly knowledgeable and extremely insightful members to our already strong and accomplished Board of Directors.”

Learn more about this great Arizona life science company at necteromedical.com

2024 AZBio Fast Lane Honoree:

The Patient Company

EASING LATERAL PATIENT TRANSFERS

Sometimes, something that seems simple can present a significant healthcare challenge. The process of moving a patient from a hospital bed is one of these “simple” processes.

A lateral transfer is when a patient is moved from one surface to another, such as a bed to a hospital cart or a bed to a gurney. Patients are frequently moved from one surface to another during their stay, for many clinical reasons. Unfortunately, this highly manual task is known to cause injury to both patients and staff.

Lateral patient transfers results in nearly 20,000 injuries to healthcare workers nationally per year.

To address this challenge, The Patient Company created SimPull, the first automated lateral transfer device. This innovative medical device allows for safe and effective movement of patients from one flat surface to another by just one caregiver, using zero work force. Not only is this new process using SimPull safer and more efficient for the caregiver, but it also makes the process easier and safer for the patient.

The Patient Company is being honored with a 2024 AZBio Fast Lane Award on September 18, 2024, at the Phoenix Convention Center for having achieved outstanding milestones in the past 18 months.

Through the development and commercialization of new medical devices and products, The Patient Company aims to redefine what a medical device/product provider should be. The Patient Company is dedicated and focused on improving quality, clinical safety, and employee satisfaction, understanding that these goals are all centered around one clear task: providing clinical staff members with superior tools to better take care of their patients.

Over the last year, The Patient Company has completed two clinical studies with major partners and listed SimPull with the FDA, allowing for commercial activities. The company published

2 patents, and further developed SimPull for other patient movements such as supporting patients being moved from a lying to seated position.

The Patient Company began initial deliveries to commercial accounts in 2024. Over the next 12 months, their goal is to increase awareness of SimPull, complete their first full year of sales and increase headcount for expanding operations.

While SimPull is the first automated lateral transfer product, there are further functions in the works. Specifically, SimPull is already able to move patients from a supine (lying on their back) to seated position, as well as boost patients in bed. These two patient movements are also well known for causing injury to caregivers. In addition, SimPull is being developed to rotate patients; supporting turning and proning patient movements and to provide insights through data capture on all of the patient movements SimPull supports.

“The Patient Company is changing the medical landscape with the SimPull,” shares Andrew Heuerman, CEO of The Patient Company. “We are poised to not only disrupt the patient transfer market, but to create tangible positive impact for our incredible healthcare workers and the patients they care for.”

Learn more about this exciting Arizona-based company at thepatientcompany.com

2024 AZBio Fast Lane Honoree: PriZm Therapeutics

TACKLING A RARE CHILDHOOD DISORDER

According to the National Institutes of Health (NIH), there are more than 7,000 rare diseases. Allan-Herndon-Dudley syndrome (AHDS), also known as MCT8 deficiency, is a rare genetic disorder that affects a child’s cognition, mobility, and overall health. In individuals with AHDS, thyroid hormone is unable to enter cells in the brain because of a defect in a thyroid hormone transporter called MCT8. Thyroid hormones are particularly important for proper brain development during pregnancy and early childhood.

This devastating and rare disease affects infants and young children. The effects continue into adulthood leaving patients to live with severe neurocognitive disability including the inability to walk, talk and care for themselves.

PriZm Therapeutics is a late-stage clinical biotech company developing therapies for ultra-rare pediatric orphan diseases based in Chandler, Arizona. The PriZm team is currently focused on developing a cure for MCT8 deficiency.

PriZm’s lead asset SRW101, is a small molecule, oral thyroid hormone analog that is in clinical trials to (1) Treat pregnant mothers who are known carriers of male MCT8 deficient fetus (2) Treat affected boys between the ages of <1 year to 17 years.

SRW101 is unique as it crosses the blood-brain barrier through alternate transporters and is MCT8 independent. Hence it produces a Thyroid Hormone response in the brain and inhibits the intracellular production of T3 in peripheral organs. SRW101 also crosses the pla-cental barrier and has received a pre-natal

Investigational New Drug (IND) Authorization from the U.S. Food & Drug Administration to treat a male affected fetus by the mother taking the oral drug during pregnancy.

AHDS is an X-linked genetic disorder with a 50% chance that male babies will have the disorder if their mother is a carrier of the abnormal gene that codes for the MCT8 thyroid hormone transporter protein. While the disorder may develop spontaneously during fetal development, where the baby is the first person in the family to have AHDS, it is more common for family history to be an indicator that doctors look for when working with expectant mothers.

PriZm is advancing its lead program, SRW101, for the treatment of AHDS/MCT8 Deficiency. The Company has an ongoing clinical trial for SRW101 via a pre-natal track in the near-term and a longer-term goal to continue to advance towards a Phase 3 trial for a post-natal track for SRW101, thus providing a comprehensive therapeutic solution to meet this unmet medical need.

PriZm Therapeutics is being honored with a 2024 AZBio Fast Lane Award on September 18, 2024, at the Phoenix Convention Center for having achieved outstanding milestones in the past 18 months and, more importantly, for the impact the company is already making as SRW101 moves through the clinical trials process.

“Prizm Therapeutics is focused on advancing innovation that improves human health and well-being. We have assembled a team of world class experts in the study and treatment of AHDS, drug development leaders, and business executives to advance SRW101 for AHDS,” states Dr. Kiran Avancha, CEO & CoFounder of PriZm Therapeutics. “Our team is driven by science, knowledge, and compassion to provide a first-in-class solution for patients and their families who are impacted by AHDS.”

Learn more about this exciting Arizona-based company at prizmtx.com

ARIZONA BIOINDUSTRY ASSOCIATION

2024 Arizona Bioscience Service Award:

Jack and Barbara Kavanagh

A 33-YEAR CANCER JOURNEY BENEFITS PATIENTS AND CAREGIVERS

Jack and Barbara Kavanagh, founders of the Arizona Myeloma Network and Cancer Caregivers of America, will be honored with the AZBio Service Award at the 20th annual AZBio Awards on September 18, 2024, at the Phoenix Convention Center.

In June of 2024, Jack Kavanagh’s 33-year journey with Multiple Myeloma ended. His experience living with cancer, and his wife Barbara Kavanagh’s journey by his side as a cancer caregiver formed the basis of their mission to provide education and support to others who are on their own cancer journeys.

Jack and Barbara Kavanagh had each other and the support of some of the leading cancer researchers and care teams in the country, but they also saw so many others around them who were struggling.

A person is considered a cancer survivor from the time of diagnosis through the balance of life, according to the National Cancer Institute. NIH data reports that in 2022 there were over 18.1 million cancer survivors in the United States. This represents approximately 5.4% of the population. The number of cancer survivors is projected to grow to 26.0 million by 2040.

With 53 million adults serving as unpaid caregivers in the United States, the importance of examining the challenges caregivers face is essential. Caregivers of people diagnosed with cancer, estimated to be more than 6 million, have additional economic and well-being risks relative to caregivers of other adult patients.

Based on their experience and with the encouragement of leading cancer experts, Jack and Barbara embarked on a mission beginning 25 years ago.

SERVANT LEADER: Barbara B. Kavanagh is the founder and CEO of Arizona Myeloma Network (AzMN). (Provided photo)

They co-founded the Arizona Myeloma Network to provide patients and caregivers with education and support that can help to navigate a cancer diagnosis and its effects on the patient, caregiver, family and community.

In 2023, the Online Cancer Caregivers Education Program launched. CCEP© has received praise from City of Hope, Pfizer, Users, and others who recognize the impact the education, access to resources, and support provided in the program can have on patients and caregivers.

Developed with leading professionals in the oncology space along with patients and cancer caregivers, the CCEP has three primary functions all housed on a platform

designed for the caregivers AND patients including:

1. Interactive and engaging education modules that focus on skill development.

2. Access to a repository of resources housed in the Cancer Care Resource Library.

3. Access to a national Cancer Care Community where patients and caregivers find support.

Jack and Barbara developed the program to help millions of patients and families, including and especially those in the underserved populations such as Native Americans and others in rural areas of the country. They worked together on it every day up until the day that an aneurism brought Jack’s cancer journey to a close.

Shortly before his death, Jack Kavanagh wrote: “Our goal is to provide knowledge and skills for the caregiver and patient so that the gaps between research and development, the administration of treatment therapies by healthcare professionals, and the impact to patients once they are home is closed. Only then we will have a complete understanding of how best to treat, heal, and cure cancer.”

Today, Barbara Kavanagh, through Cancer Caregivers of America, is continuing the mission and Jack’s legacy.

“The education and support provided by the healthcare professionals delivering treatment therapies to cancer patients are exceptional. Unfortunately, education and support for the cancer caregivers who are providing critical care at home are virtually nonexistent. While we as a nation have come a long way over the past few years regarding providing information and access to resources for our caregivers, we still have a long way to go,” she says. “And we know we can help.”

DOUBLE UP Arizona’s life science cluster sets goal to double economic impact by 2033

As the Arizona Bioindustry Association (AZBio) celebrated 20 years of impact and growth in Arizona’s life science sector in 2023, it also called on the community to embrace a new and bigger goal — to double its economic impact metric by 2033.

Economic impact is one of the most encompassing metrics. It includes the direct impacts of employment and wages within the industry, the indirect impacts generated by supply chain partners and supporting industries, and the induced impacts created when the direct and indirect workforce has more personal income to spend.

Arizona’s Life Science Industry, not

including our hospitals, generated $38.54 billion of economic impact in 2021. This includes $3.63 billion in direct employment impacts and $34.9 billion in indirect and induced impacts. Nationally, Arizona ranked 22nd for economic impact in 2021 as compared across the U.S. States plus Puerto Rico and Washington, D.C. Updated data, reflecting the results for 2023, will be released by AZBio before the end of 2024. Industry focused construction and real estate development significantly contributes to driving the growth of indirect impacts. With over 6 million square feet of life science facilities in place or planned on the 30-acre Phoenix

Bioscience Core (PBC), an ever-expanding health innovation ecosystem on the 100-acre Phoenix Medical Quarter in Midtown, and Mayo Clinic’s expansive 120-acre Discovery Oasis development in North Phoenix, Phoenix is at the heart of a statewide life science ecosystem that stretches from Flagstaff to Tucson.

Achieving the goal of doubling by 2033 is doable if Arizona continues to act strategically and invests in the key resources life science companies need to grow.

Growing Arizona companies, including companies that started here or come here to leverage Arizona’s advantages, grow best when they are well capitalized.

Money Matters

Arizona offers significant cost advantages as compared to other major life science markets. This allows companies to better deploy precious capital resources.

Life science companies require innovative ideas, talented people to move the ideas forward, and capital to take the ideas and convert them into products and services that create both economic and societal impact.

Arizona is home to several angel investment groups and investment firms that focus on the life sciences but does not have enough to fuel the anticipated growth. Increasing access to capital is a strategic imperative as we work to double our impact by 2033.

In 2022, the State of Arizona created the foundation for the Arizona Health Innovation Trust Fund (AHIT). Designed to accept monies from private interests and public funds, AHIT is designed to function as a permanent endowment with the Arizona State Treasurer serving as trustee and the Arizona State Treasurer’s Office as the investment manager for AHIT. The goal is to build the endowment to $200 million through donations and appropriations and then have it grow organically from that point forward. Each year, AHIT will distribute 4% of AHIT’s 5-year average balance to an Arizona-based 501c3 nonprofit organization that will execute three

key components of Arizona’s health innovation growth strategy.

The Opportunity Through Entrepreneurship Foundation (OTEF) was selected by the State of Arizona to do this work. AZAdvances, an initiative created within OTEF and supported by AZBio, is structured to educate, and support life science entrepreneurs, make mission related investments, and develop the workforce Arizona will need as the life science ecosystem grows. Arizona ranked 25th nationally for venture capital investment in 2021. Increasing the level of life science investment requires increasing the number of Investable Companies in Arizona.

Investors evaluate companies based on their potential return on investment. For early-stage companies, the science behind the product or service and the potential market for what they are creating is important. Having a qualified team that can execute the business plan is essential. Investors need to believe that the team can get the job done and that their investment will pay off. Investable companies demonstrate this by achieving key milestones in the business plan and progressing in the commercialization process. AZAdvances programs are designed to help more early-stage Arizona life science companies become investable so they can grow faster.

Growing companies create more jobs. This means that Arizona needs to develop its workforce. The AZAdvances Talent program is designed to help develop our workforce and provide Arizona students the opportunity to make connections and gain real-world experience inside the growing entrepreneurial companies AZBio and AZAdvances support.

Doubling the economic impact of Arizona’s Life Science Sector matters.

Arizona’s research centers are focused on discoveries. Societal impact is the effect of research on the world outside of academia.

Entrepreneurs build on these discoveries to develop and deliver the products and services that can make a positive impact on people’s lives.

This societal impact can be measured:

• Better health outcomes for patients

• Healthier communities that deliver increased overall workforce productivity

• Lower healthcare costs through improvements in healthcare processes

• More rewarding, high quality jobs

• Increased direct and indirect economic impacts through increased employment.

• Growing our tax base to support education, public safety, community programs, infrastructure, and capacity building.

Societal impacts make life better for people across Arizona, not just for a single company or industry. They matter. That is why we are committed to achieving our goal. We invite you to join us in making it happen.

Arizona’s life science cluster is on a mission to be a Top 10 life science state and to double its economic impact by 2033

Editor’s note: 2033

ARIZONA BIOINDUSTRY ASSOCIATION

LIFE SCIENCE INFRASTRUCTURE

INNOVATION HUB: The 30-acre Phoenix Bioscience Core includes over 2 million square feet of life science facilities and is planned to grow to over 6-millon square feet. (Photo courtesy of Phoenix Bioscience Core)

Arizona’s Life Science Sector is growing rapidly and reached more than 39,118 jobs spanning 3,350 business establishments in 2022. Bioscience industry jobs increased by 14.8% between 202022 compared to the U.S. average of 11.1% growth according to data reported by the Flinn Foundation in 2024. This continued the trend reported by the Kem C. Gardner Policy Institute at the University of Utah that showed that Arizona ranked No. 2 in the nation for 10-year average job growth (2012 to 2021). Only Massachusetts consistently grew more.

Arizona is also seeing rapid growth in the amount of life science infrastructure under construction and development. AZBio’s Infrastructure Council is comprised of leaders from across Arizona’s life science ecosystem with a shared goal to raise awareness of Arizona’s Advantages among life science companies and site selectors nationally and internationally.

Arizona Advantages

• Reach 65% of the U.S. population by air within two hours and by land within 24 hours

• No natural disasters to disrupt your supply chain

• Business-friendly policies and support

infrastructure

• 100 Years of Water thanks to Proactive Management, Planning and Policies

• Research 1 universities and the largest community college district in the U.S.

• Respected clinical partners: Banner Health, City of Hope, Dignity Health, HonorHealth, and Mayo Clinic

• World-class research partners: Arizona Alzheimer’s Consortium, Arizona Heart Hospital, ASU Biodesign, Barrow Neurological Institute, Norton Thoracic Institute, UArizona BIO5, Critical Path Institute, Phoenix Children’s Hospital, TGen, UArizona Health Sciences

• Medical schools: Creighton University, Mayo Clinic Alix School of Medicine, Midwestern University, University of Arizona College of Medicine Phoenix, University of Arizona College of Medicine Tucson

• Veterinary schools: Midwestern University and University of Arizona Infrastructure council members are also expert at helping companies assess the operating cost advantages of locating and growing life science businesses in Arizona and identifying state incentive programs that support that growth including Arizona’s: Quality Jobs Tax Credit program which provides up to $9,000 of income

or premium tax credits over a threeyear period for each net new job to the state and concurrent qualifying capital expenditures.

Research & Development Tax Credit program which provides an Arizona income tax credit for increased research and development activities conducted in this state.

Additional Depreciation program that accelerates depreciation to substantially reduce business personal property taxes.

Qualified Facility Tax Credit program that offers a refundable income tax credit for companies making capital investments to establish or expand facilities.

Angel Tax Credit program that provides tax credits to investors who make capital investments in small businesses certified by the ACA.

ARIZONA BIOINDUSTRY ASSOCIATION

AINVESTING IN INNOVATION

rizona leaders began to focus on developing Arizona’s bioscience cluster in 1997, and the growth since then is significant. Thanks to a series of strategic decisions and investments, Arizona is home to one of the fastest growing health innovation ecosystems in the country on a percentage basis. Today, Arizona’s Bioscience Roadmap is the longest running, continuously managed strategic plan to grow a bioscience sector in the country. Launched in 2002 and stewarded by the Flinn Foundation, the Roadmap, like all good plans, has regularly reported results, and engages stakeholders to take the actions that drive results.

Arizona ranks No. 2 in the nation for Life Sciences Job Growth based on the 10-year average (2012-2022) calculated by the Kem C. Gardner Policy Institute, part of the David Eccles School of Business at the University of Utah. Only Massachusetts ranked higher.

Since the cluster was formed 27 years ago, over $29 billion in public and private funds have supported the creation of life science infrastructure, launched new medical schools and educational programs, fostered the growth of talented students and entrepreneurs, contributed over $1.7 billion to university research under TRIF, and expanded our healthcare delivery systems to meet the needs of Arizona’s growing population.

Arizona’s life science sector delivered $38.54 billion in Economic Impact in 2021. That’s impressive. We won’t stop there. The goal is to double this impact to $77 billion by 2033. Leaders across Arizona are putting on the pin to show their commitment to achieving this goal and encouraged to share with others what their role is in making it happen.

Moving up

Being ranked No. 2 in the nation for Life Sciences Job Growth is something to be proud of, but metrics like this look at percentage growth rather than the real number of net new jobs.

It helps to look at the real numbers on a comparative basis. The chart below compares Arizona and Massachusetts. The states have similar populations. Massachusetts is home to a mature life science ecosystem and Arizona is home to an emerging ecosystem. Both states made significant life science investments of $1.5 billion between 2003-2017. Arizona invested in university research infrastructure. Massachusetts, already mature in 2003 and home to 24 Research 1 universities, put their funds into the Massachusetts Life Science Center initiative and spread their investment across research, workforce, and investment programs to drive the growth of their companies.

Without a doubt, Massachusetts has some distinct advantages as a mature market. Thanks to strategic investment into its early-stage companies over the last decade, the state has a strong pipeline of investable companies. Venture Capital invested into Massachusetts life science companies (2018-2021) was $3.2 billion compared to $565 million for the same period in Arizona.

For Arizona to rise to be a top-10 life science sector and reach mature market status, we need to continue to make strategic investments that are balanced across the spectrum from the discovery phase and on to the development phase where products and services can be created by local companies and ultimately improve the lives of people in Arizona and around the world. The work has begun with initiatives like the Arizona Health Innovation Trust Fund and AZAdvances. As we prepare for Arizona’s next stage of life science growth, it’s time to turn the page.

ARIZONA BIOINDUSTRY ASSOCIATION

ARIZONA HEALTH INNOVATION TRUST FUND

The Arizona Health Innovation Trust Fund (AHIT) is designed to be a growth engine driving Arizona’s life science sector as it progresses from an emerging ecosystem to a mature ecosystem. AHIT was created by statute in 2022 and established under the Arizona State Treasurer’s Office (ASTO) with the State Treasurer as trustee.

The purpose of the Arizona Health Innovation Trust Fund is to help small, Arizona-based life science companies grow here and to provide more training programs to support their growing workforce needs. With this support, the companies will create high quality jobs, drive economic growth, and, most importantly, support the development of Arizona discoveries that can become life-enhancing treatments and possibly lifesaving cures.

This all starts with capitalization of the Arizona Health Innovation Trust Fund.

Arizona’s health innovation sector is the beneficiary of over $29 billion in public and private investments in its discovery and healthcare delivery infrastructure over the last 20 years. The result, in the year 2021 alone, was over $38 billion in economic impact.

The process of creating health innovations has three parts: discovery, development, and delivery. This middle component, development, is the bridge that

discoveries originating at our universities, hospitals, and small businesses must cross before they can create a benefit for the people who need them. Arizona’s development infrastructure also must be supported. That is what AHIT is designed to support.

Arizona leaders have embraced a goal to make Arizona home to a top-ten life science sector. The impact of reaching top-ten status will be significant. In 2021, the No. 10 state had an economic impact of over $78 billion. Arizona’s life science community is working to double the economic impact generated by Arizona’s life science sector by 2033, moving our state towards a place in the top-ten ranks nationally.

The intention is for AHIT’s balance to grow to not less than $200 million through funding from a mix of public and private sources including, but not limited to, state or federal funds as well as donations from private individuals and organizations. Arizona’s AHIT investments are managed by ASTO. Beginning in FY27, the Arizona State Treasurer’s Office (ASTO) will make distributions of 4% of the 5-year average balance on an annual basis to an Arizona 501c3 public charity to fulfill the statutory requirements and will:

• Provide entrepreneurial education, mentoring and support to persons in the health innovation and health care delivery sectors.

• Provide programs that support

workforce development.

• Provides programs that support the development and commercialization of health innovation.

The non-profit entity must annually submit a report, as prescribed by the Treasurer, to the Governor, the President of the Senate, the Speaker of the House of Representatives, and the Treasurer by each December 31.

The current estimate of the funds needed to bridge Arizona’s health innovation development gap is $10 million per year. As the sector grows, the need will grow. Under AHIT’s endowment model, the core investment capital will grow to meet this need. Like the trusts established under ASTO that are managed for Arizona’s cities and towns, investment returns on the core capital continue to grow and replenish the trust.

The Opportunity Through Entrepreneurship Foundation (OTEF) is contracted with ASTO to be the nonprofit that will deliver these services as programs under the AZAdvances initiative.

No funding was appropriated by the state in FY 24 or FY25 due to budget challenges. Capitalizing the Arizona Health Innovation Trust Fund is an investment in Arizona’s future that will yield both economic and health impacts that benefit Arizona and for Arizonans today and for generations to come.

In 2025, Arizona’s elected leaders will have the opportunity to support AHIT as part of the FY26 budget process. This investment in Arizona’s future continues the process that the Senate, House, and Governor began in 2022.

ARIZONA BIOINDUSTRY ASSOCIATION

AZAdvances: OPPORTUNITY THROUGH ENTREPRENEURSHIP FOUNDATION

AZBio began working with the Opportunity Through Entrepreneurship Foundation (OTEF) in 2014 when the organizations came together to create the Student Discovery Zone at the AZBio Awards. Since 2014, over 1400 students have had the opportunity to showcase their research projects, make industry connections, and compete for merit-based scholarship awards.

In 2019, the collaboration expanded to include three focus areas: Talent, Entrepreneurial Support, and Missionrelated investments so that Arizona startups reach key milestones and can attract the levels of capital they need to grow.

The Arizona Health Innovation Trust Fund (AHIT) is designed to be a growth engine driving Arizona’s life science sector as it progresses from an emerging ecosystem to a mature ecosystem. AZAdvances is the

vehicle that will move us forward as we progress into the top-10 life science rankings nationally.

AHIT’s first distributions to OTEF for AZAdvances do not begin until 2027, and based on the current AHIT levels, this means that all progress to date is thanks to donations from the community to OTEF. This has allowed AZAdvances to:

• Host six Student Discovery Zone. Programs benefiting hundreds of students.

• Award 36 merit-based scholarships.

• Employ 5 student interns and deploy them at small Arizona life science companies so that the students gain the experience of being part of an entrepreneurial venture.

• Gather the community for education and inspiration at the AZAdvances

Innovation Showcase at the ASU Health Futures Center.

• Make our first 3 mission-related investments into local life science startups.

• Use these pilot programs to establish the processes needed to scale the program as soon as more funding is available from charitable donors, grant making organizations, or AHIT.

Community support in 2024 guides the level of program impact that can be delivered in 2025. During Arizona Bioscience Week, two great Ponte Cura events support AZAdvances. In addition, donations are always welcomed at AZAdvances.org/donate. Be sure to check out the donor wall to see community members who are coming together to help drive health innovations forward in Arizona.

ARIZONA BIOINDUSTRY ASSOCIATION

ATTRACTING INVESTMENT

In June of 2024, J.P. Morgan Life Sciences Private Capital closed its inaugural biotechnology venture capital fund with over $500 million in commitments. This is no small feat, even if you are J.P. Morgan.

Dr. Stephen Squinto, Chief Investment Officer and Managing Partner of J.P. Morgan Life Sciences Private Capital shared the following. “As investors and company builders, we are strongly positioned at J.P. Morgan Private Capital to identify and support highly innovative companies that can shape the future of how patients are treated. Our mission is not only to capitalize companies, but also to utilize our collective experience to guide them towards successful outcomes, and to mentor a new generation of biotechnology founders and executives.”

Building a successful life science company is also no small feat. Life science entrepreneurs need to figure out how to build a business, usually on a very tight budget, move the science forward, choose the right partners and experts, manage supplier and investor relationships, and a multitude of other tasks. These things

all take money and lots of it. Since most company founders are not independently wealthy, and the odds are not good that a lottery ticket will save the day, they must convince potential investors that they have an “investable” company.

Much has been said and written about what makes a company investable. In reality, every investor is different. There is no magic formula or calculation that you can plug into a system and receive a golden ticket to investor success. Even the most successful health innovators will tell you to be prepared for rejection. Just getting an investor to agree to a meeting can be difficult and it’s not unusual to have 100 meetings before you get to a yes.

AZBio created the White Hat Life Science Investor Conference in 2014 to bring together high potential companies with investors. Across 5 conferences and after interacting with hundreds of investors, many who have returned for every conference, we have gained deep insights on the factors that impact an investor’s decision process. Here are some of the most common questions investors ask themselves:

People, people, people

Especially in the early-stages, people are a key decision factor.

• Can the team work together?

• Are they able to listen and willing to work with the investor?

• Does the team include people with the needed skill sets?

• Does their past experience or track record instill confidence?

A plan and the ability to execute

Peter F. Drucker’s teachings have a significant place in modern management theory. Drucker taught that “Strategy is a commodity, execution is an art.” Great, exciting, and often audacious business plans are presented to investors on a regular basis. It is up to the company seeking investment to convince the investor that the plan is reasonable and that the team is able to do what they say they can do. There are no guarantees of success with any startup but the ability to execute is essential.

The life science startup space is extremely unpredictable. Even the “best”

FDA approval process, to obtaining reimbursement from government and private payors, to gaining adoption from both the prescriber and patient communities, and maintaining manufacturing, quality, and delivery systems, investors must assess how confident they are that this company, with this team, can go the distance.

• Can the company raise the capital it will need to travel this journey?

• Does the team have the business experience needed to scale?

• Are budgets and projections realistic? What are the contingency plans?

• Will the company use the investment in the most efficient and impactful way?

• Does the company have a strong intellectual property portfolio — and — what will it cost to maintain it?

Market, ROI and exit potential

Investors need to make a return on their investment and often within a set time. That means there must be exit potential.

• Is the market big enough to generate a return on investment that matches my investment needs?

is the potential to make an investment. If not, they will pass.

Large venture capital firms, family offices that focus on the life sciences, and institutional investors have teams of business leaders and scientific experts who focus heavily on due diligence. Other investors may decide to follow as part of a round led by these investors. Syndicated investments like this normally have a lead investor combined with the investments of others to reach the round’s targeted level of investment. This is both a way to share due diligence and a way to spread the investment risk across the syndicate.

Individual investors, often called angels, may band together in organized groups to share due diligence on the companies they have an interest in. In most cases, the individual angels then make their own decisions and their own investments. The Desert Angels in Tucson and ATI (Arizona Tech Investors) in Phoenix are examples of Arizona based angel groups that have developed a track record for life science investment.

science does not always pan out the way a team thinks it will. What looks good in pre-clinical work may turn out differently in later stages as human trials begin or progress. If this happens, and it often does, can the team pivot and still move forward? Even when the science is working in a company’s favor, other factors related budgeting, availability of key resources or components, available talent and workforce, and other operational factors are common challenges.

• Does the team have the ability to adapt and to overcome these challenges?

• When the plan changes, which it almost always does, will leadership be transparent, communicative, and open to suggestions from advisers and investors?

• Does the company have good governance policies in place?

Life science business savvy

Beyond the business basics, does the team have the expertise to navigate the parts of the journey that are unique to life science companies? As the development process moves from navigating the

• Will an exit event, when the investor realizes their return, have a high potential to occur when it is needed?

• Are there potential buyers for the company or potential strategic investors who might buy out our investment?

The due diligence process

Investors ask these questions and more as part of what is called a due diligence process. After they get the answers, they compare what they have learned to their own internal guidelines for investment. If the calculation of investment reward less the investment risk is positive, there

Looking back up at the list of questions that are common as part of the due diligence process, it is easier to understand why many young companies will have so many meetings to raise their initial investments. Until they do, it is extremely difficult to reach the milestones that will make them “investable.”

Here in Arizona, organizations including the Arizona Commerce Authority, our universities, the Flinn Foundation, incubators and accelerators, AZBio, and now AZAdvances work together to help support the companies on their journey to become investable and continue to support them as they grow.

WHITE HAT INVESTMENTS

$2.4 billion:

The amount invested into White Hat presenting companies since presenting at White Hat in 2014, 2016, 2018, 2020 and 2022.

ARIZONA BIOINDUSTRY ASSOCIATION

CLINICAL TRIALS IN ARIZONA

State ranks 9th in the U.S. and No. 3 in western states

Clinical trials are research studies that are central to medical advances and are the primary way researchers determine if new treatments are safe and effective. They can help improve the health of current and future generations by looking for new ways to: prevent disease, detect disease, treat disease, and improve quality of life.

Clinical trials can test a variety of interventions, including:

• New drugs or combinations of drugs

• New surgical procedures or devices

• New ways to use existing treatments

• New ways to change behaviors to improve health

These studies can help researchers determine if a new treatment is more effective or has fewer side effects than existing treatments. They can also help researchers learn how to safely use a treatment in populations where it hasn’t been tested on before, such as children. Clinical trials are always voluntary, and

participants can stop at any time if they feel uncomfortable. Before participating, participants receive an informed consent document from an institutional review board (IRB) that explains the trial’s safety, risks, benefits, and other important information. Not everyone in a clinical trial has an illness or condition. Many clinical trials also include healthy subjects. This is where people volunteer to be part of the trial and can be compared to people with health challenges. This is especially common in vaccine trials where researchers are looking to see if the vaccine prevents you from getting sick. For example, across all the manufactures of Covid-19 vaccines, over 1 million healthy subjects from around the world volunteered and participated in one or more trial phases.

Without clinical trials, the treatments people are waiting for will not get to them.

Arizona’s diverse population, deep base of clinical expertise, and thriving health innovation ecosystem combine to make our

All of Us Research Program

state a leader in clinical trials.

Analysis of clinical trials economic impact data published by the Biotechnology Innovation Organization (BIO) reveals that Arizona ranks ninth in the United States for economic impact generated by clinical trials activity, 3rd in states West of the Mississippi, and 1st in the Rocky Mountain Southwest. We use economic impact as a key indicator to compare from state to state as it includes the number of people participating in the trials and the cost to run them.

Here in Arizona, some of our leading clinical trial sites include Banner Health, Dignity Health, HonorHealth, Mayo Clinic, and Phoenix Children’s Hospital. Dignity Health St. Joseph’s Hospital and Medical Center is part of CommonSpirit Health, the 5th largest health system in the United States. More clinical trials are hosted at St. Joseph’s than any other hospital in the CommonSpirit network.

The All of Us Research Program is a historic effort to collect and study data from one million or more people living in the United States. The goal of the program is better health for all of us.

The program includes racial and ethnic minorities as well as sexual and gender minorities, people with low income or limited education, and other groups. According to NIH, the demographics include ~45% racial and ethnic minorities; +80% underrepresented in Biomedical Research

As of May 2024, Arizona has fully enrolled over 71,540 people in the program, second only to California with 75,100. That’s impressive since California’s population is five times that of Arizona.

ARIZONA BIOINDUSTRY ASSOCIATION

IPUBLIC POLICY AND INNOVATION

n the 2024 legislative session almost 1,500 bills were introduced in the Arizona House of Representatives and in the Arizona Senate. Bills in Arizona must progress in a single session which lasts approximately 100 days. In 2024, the Arizona Legislature passed 330 bills. Of these, 258 were signed into law and 73 were vetoed by Governor Hobbs.

In Washington, bills are introduced and can be passed during a two-year Congress. In the 118th Congress (20232024), over 15,000 bills have been introduced and as of September2024, 270 have been passed. President Biden vetoed 12 of them.

After a bill becomes law at the state or federal level, it goes to the relevant agency for the rules and regulations to be written and implemented.

With this volume of legislation and regulation, it is not reasonable to expect that all of them are perfect. In fact, many well intended laws can come with significant unintended consequences.

AZBio works to serve as a reliable and trusted resource to our elected and appointed leaders on issues and opportunities that affect our bioscience industry, our communities, and our state.

AZBio Members include patient advocacy groups, educators, economic developers, health innovators, and our healthcare systems.

AZBio’s leaders look at public policy through three lenses: 1) is the policy good for patients; 2) does it support improve the quality and reduce the cost of healthcare delivery; and 3) does it support the growth of our industry.

The IRA is an example of intended and unintended consequences.

August 16, 2024 marked the two-year anniversary of the Inflation Reduction Act (IRA). One of the most talked about and written about policies of the current administration, the IRA has far reaching impacts. Whether they are positive or negative is a matter of perspective.

Like many complex pieces of public policy, there are some things that are very good and others that may have unintended consequences that keep the policy from having its intended benefit.

The health provisions of the Inflation Reduction Act were intended to lower healthcare spending by patients and by the largest healthcare payer, the U.S. Government.

The IRA put a much-needed cap on

senior’s out-of-pocket costs, it also contained some very damaging provisions that are slowing down the development of newer and better medicines that can improve quality of life and potentially reduce healthcare costs overall.

Medicine development is a long and complex process. The IRA fundamentally alters the incentives for medicine development and the negative implications of these changes are beginning to be felt today. It will be decades before the full damage can be measured.

Companies are already changing their research programs due to the law and noticeable shifts have occurred in the types of new products investors are investing in.

Experts predict this will result in fewer treatments for cancer, mental health, rare diseases, chronic diseases, and other conditions that are the main drivers of healthcare spending.

Just as laws are written and passed, they can also be improved upon over time. AZBio and AZBio Members gather the evidence of what is working, and what is not. We share this data with our elected leaders so that they can improve on current public policy and can create better policies that benefit all of us in the future.

WHAT THE FUTURE HOLDS

A note from the AZBio president and CEO

This year’s special section in Az Business magazine provides a glimpse of what is happening in Arizona’s health innovation sector today.

As AZBio’s president and CEO, I have the enormous privilege of working with Arizonans as they strive to make the world better by creating innovations that are improving animal and human health and can do even more in the future. As I meet with people to share what’s happening in Arizona, in meeting after meeting and from conversation to conversation a theme emerges — what’s happening in Arizona is amazing.

Arizona health innovators are working to create treatments and cures that can improve our quality of life, create better health outcomes, and support a thriving life science ecosystem.

Arizona educators are helping our future researchers, innovators, and leaders develop the knowledge and skills that they will need to make a difference during their careers. Arizona leaders are working to double

PUT A PIN ON IT: Arizona pins are available at all AZBio events. Get yours during Arizona Bioscience Week. (Provided photo)

the economic impact of our life science sector by 2033 and with it the high paying jobs that today’s students hope to work in.

Arizona patient advocates keep us grounded and focused on our industry’s most important mission, to make life better for people everywhere.

We don’t have a time machine to take us forward but based on what Arizonans are working on here’s the future I see…

• A world where we can say, “People used to get cancer.”

• Golden years where people keep their memories and don’t live with the fear of Alzheimer’s Disease.

• Medical devices that improve the lives of people with neurological conditions the way they help people with heart conditions today.

• Therapies that can repair damaged organs, so we don’t have to replace them.

• Gene and cell therapies that can treat diseases or better yet, cure them.

• Arizona is home to the largest health innovation trust fund in the United States and continues to drive health innovation forward as AZ advances.

AZBio embraces its vision of Arizona as a top-10 ranked life science state and works with its members to make this vision a reality.

Join us as we move into the future. Get engaged. Put on the Pin. Spread the Word. Start investing. Keep Innovating! Arizona’s life science sector is amazing, and we are just getting started!

ARIZONA LIFE SCIENCE TODAY

• $29 billion-plus invested into building the Arizona life science sector over 20 years — 2002-2022

• $38.54 billion in economic impact in one year (2021)

• No. 2 nationally in life science job growth based on a 10-year percentage

• No. 9 in clinical trials nationally

• The Ivy Brain Tumor Center is home to the largest Phase 0 clinical trials program in the world

• Home to five medical schools and two vet schools. (20 years ago there was only one medical school in Arizona)

• ASU ranked No. 1 for innovation every year since the innovation rankings began

• Arizona’s Bioscience Roadmap is the longest running, continuously managed, strategic plan to build a bioeconomy

Joan Koerber-Walker AZBio

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