Tag Archives: Insys Therapeutics

research

Clinical trials change Arizona’s bioscience, business sectors

Last November, Arizona voters resoundingly passed Prop. 303 making it legal in Arizona for companies and physicians to provide terminally ill patients the “right to try” investigational drugs or therapies outside an FDA approved clinical trial.    While it sounded good in the short description provided to voters, in reality, it is unlikely to provide the outcomes one might expect since the manufacturers, physicians, pharmacists, and hospitals are required to follow the federal processes that govern these investigational treatments.  Proposition 303 did not change that.

What Are Clinical Trials?

The clinical trials process is an important step in the discovery, development and delivery pathway that leads to new life saving and live enhancing innovations.  Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for patients. These studies also may show which medical approaches work best for certain illnesses or groups of people. Clinical trials produce the best data available for health care decision making and the studies follow strict scientific standards. These standards protect patients and help produce reliable study results.

Today, in Arizona, there are 1,380 ongoing clinical trials according to ClincialTrials.gov which is the national database provided by the U.S. National Institutes of Health.  These studies cover a wide range of therapies and conditions.  Through the dedicated work of innovators, healthcare professionals, and patients, we are learning more about the safety and effectiveness of future treatments.

ClinicalTrials.gov  is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world and currently lists 187,600 studies with locations in all 50 states and in 189 countries.

How can we speed the path to innovation and give more patients access to life changing innovations?

On April 29th, members of Arizona’s life science industry and members of the community at large will gather the Sheraton Phoenix Downtown for the 2015 AZBio Expo which will focus on clinical trials in Arizona. Event details and ticket information for the 2015 AZBio Expo on April 29, 2015 at the Sheraton Phoenix Downtown are available at AZBioExpo.com.

Thanks to the support of leaders in Arizona’s life science community, practicing physicians, patients, and caregivers are invited to register for the full day conference free of charge with discount code “AZBusiness.”

The program is designed to provide an update on what Arizona’s clinical trial landscape looks like today and what is could grow to be in the future.  The program includes:

• An Introduction to The Clinical Trials Process by Mark Slater, PhD, Vice President, Research at HonorHealth Research Institute

• A keynote presentation by Matthew Huentelman, PhD, Associate Professor, Neurogenomics Division and Head of the Neurobehavioral Research Unit at the Translational Genomics Research Institute (TGen)

• A keynote presentation by Glen Weiss, MD, MBA, Director of Clinical Research & Medical Oncologist, Western Regional Medical Center, Cancer Treatment Centers of America

• A View of Arizona’s Clinical Trials Landscape by Joan Koerber-Walker, President and CEO of the Arizona Bioindustry Association and Chairman of the AdvaMed State Medical Technology Alliance in Washington, DC.

• A Discussion on Funding Clinical Trials led by Joan Koerber-Walker with Terry Urbine, PhD of the  UA College of Pharmacy, Jeremy Shefner, MD, PhD of the Barrow Neurological Institute, and Teresa Bartels from Gateway for Cancer Research.

• A Discussion on Engaging Patients in the Process led by Greg Vigdor, President & CEO, Arizona Hospital and Healthcare Association with  Brian Browne of Banner Research, Barbara Kavanaugh of the Arizona Myeloma Network, and Marcia K. Horn of the International Cancer Advocacy Network

• A Discussion on Growing Arizona’s Clinical Trials Base led by Nazneen Aziz, PhD,  Chief Research Officer and Senior Vice President, Phoenix Children’s Hospital with  Joan Rankin Shapiro, PhD of the UA College of Medicine Phoenix), and Linda Vocila, BSN, RN of TD2.

• Rapid Fire Presentations featuring Arizona companies with active clinical trials here in Arizona and around the world including:  Cancer Prevention Pharmaceuticals, Inc.,  Capstone Therapeutics,  the Center For Sustainable Health at the Biodesign Institute at Arizona State University,  Cord Blood Registry,  Insys Therapeutics, Inc., and  NuvOx Pharma.

By focusing on clinical trials together, we can help find answers for the people who matter most, the patients.

healthcare

Az Business names Healthcare Leadership Awards finalists

Each year, AZ Business magazine hosts the Healthcare Leadership Awards to honor the women, men and institutions that bring excellence and innovation to Arizona’s healthcare sector.

Az Business is proud to announce the 2015 Healthcare Leadership Awards finalists, who were chosen by a panel of industry experts and will be recognized at the Healthcare Leadership Awards dinner and awards ceremony on April 9  at the Arizona Grand Resort. The finalists, in alphabetical order, are:

Abrazo Health — Arrowhead Hospital

Abrazo Health — Michele Finney

Affiliated Urologists — Dr. Mark Hong

Banner Health, Cardon Children’s Medical Center — Rachel Calendo

Banner Health — Peter Fine

Ben & Catherine Ivy Foundation — Catherine Ivy

Blue Cross Blue Shield of Arizona

Brownstein Hyatt Farber Schreck — Martin L. Shultz

Cancer Treatment Centers of America at Western Regional Medical Center

CTCA — Dr. Glen Weiss

Dedicated Health Solutions

Dignity Health — Barrow Neurological Institute

Dignity Health, Chandler Regional and Mercy Gilbert medical centers — Tim Bricker

Dignity Health — St. Joseph’s Hospital and Medical Center

HonorHealth and TGen — Dr. Daniel D. Von Hoff

HonorHealth – Virginia G. Piper Cancer Center

IASIS Healthcare — Tony Marinello

Insys Therapeutics

Magellan Health

Maricopa Integrated Health System — Dr. David Wisinger

Medtronic

Midwestern University — Kathleen Goeppinger

Quarles & Brady — Roger Morris

Phoenix Children’s Hospital – Dr. Robert J. Arceci

Radiant Research

Remuda Ranch

Snell and Wilmer – Richard Mallery

Sonora Quest Laboratories

Southwest Behavioral Health Services

SynCardia Systems

The CORE Institute — Dr. David Jacofsky

UnitedHealthcare of Arizona

University of Arizona Cancer Center

VisionGate

angel

Bioscience innovators will pitch at White Hat Investors

Bioindustry Associations from across the Rocky Mountain Southwest Region are coming together to present an opportunity for Angels, Venture Capitalists and Strategic Investors to connect with the biotech and healthcare investment opportunities from across the Rocky Mountain Southwest states at White Hat Investors 2014 in Phoenix, Arizona on September 17 and 18, 2014.

“The West was won by innovators, investors, and prospectors who understood the value of discovery and accepted the challenge of investing in new frontiers,” shared Joan Koerber-Walker, president and CEO of the Arizona Bioindustry Association (AZBio). “Now, industry leaders and accredited investors have the opportunity to meet a new generation of biotech and healthcare pioneers at White Hat 2014, the first annual biotech and healthcare investor conference that showcases the best of the Rocky Mountain Southwest Region.”

White Hat Presenting Companies were selected from the region’s emerging innovation leaders in the fields of Diagnostics, Therapeutics, Medical Devices, and Health IT. Presenting companies are developing lifesaving and life improving innovations that will benefit people today and for generations to come while addressing some of our greatest health challenges including cancer, cardiovascular and pulmonary disease, neurological disorders, infectious disease, and more.

On September 17th, over 400 life science industry leaders will gather to view a company showcase, browse a student discovery zone and listen to presentations from local life science entrepreneurs on the BioAccel Best of the Best Stage from 3:00 p.m. – 6:00 p.m. in the North Ballroom of the Phoenix Convention Center. Free and open to the general public, it presents an opportunity for members of the community to connect with the region’s fastest growing innovation sector. The public pre-event will be followed at 6:00 p.m. by the AZBio Awards gala (registration required) honoring life science pioneer Roy Curtiss, III, PhD; Charles Arntzen, PhD, the Arizona State University Researcher who, with his team, played a key role in the development of ZMAPP, the experimental Ebola drug given to two health workers who were sickened by the deadly virus earlier this year; W.J. “Jim” Lane, Mayor of the City of Scottsdale for his work in developing the Scottsdale Cure Corridor; innovative educator Miles Orchinik, PhD of the School of Life Sciences at Arizona State University; Jack B. Jewett of the Flinn Foundation for leadership of the longest running statewide bioscience development initiative in the United States; emerging technology leaders SenesTech, Pinnacle Transplant Technologies, and Cancer Prevention Pharmaceuticals along with the 2014 Arizona Bioscience Company of the Year, Insys Therapeutics, Inc.

White Hat events continue on September 18th at the Hyatt Regency in downtown Phoenix with presentations by privately-held life science companies presenting to attending representatives of family offices, investment funds, corporate investment/business development professionals for life science oriented firms (strategic investors), granting foundations, venture capital firms, and accredited investors. In addition to great company presentations in the areas of Medical Devices, Diagnostics, Therapeutics and Health IT, White Hat includes THREE general sessions featuring panel discussions on the investment environment from the perspective of Angels, Strategic Investors, and VCs.
Presenting Companies were selected from the Rocky Mountain Southwest’s emerging innovator leaders in the fields of: Diagnostics, Therapeutics, Medical Devices and Health IT and include:

• Aviratek, LLC
• Breezing
• Calimmune, Inc.
• CardioCreate, Inc.
• Convoy Therapeutics
• DiscGenics
• Elutin Vascular Inc.
• EndoShape, Inc
• Fluonic
• Imagenonics LLC
• Iron Horse Diagnostics
• INanoBio
• Kalos Therapeutics
• Kulira Technologies
• Meditope Biosciences, Inc.
• MSDx
• NeuroRecovery Technologies, Inc.
• NuvoMed
• NuvOx Pharma
• Pediatric Bioscience, Inc
• Portable Genomics, Inc.
• MedTalk Companion (Real Phone Corp)
• Recursion Pharmaceuticals
• RiboMed Biotechnologies
• Savoy Pharmaceuticals
• SenesTech
• Skylit Medical
• Sonoran Biosciences
• T-MedRobotics
• Valley Fever Solutions
• ValveXchange
• ViroCyt
• VisionGate
• Yolia Health

bioscience

Arizona bioscience industry producing ‘aha’ moments

AZBio Expo 2014 had “aha moments” at every turn. With over 250 entrepreneurs, innovators, business leaders, legislators, scientists and researchers in attendance, the energy was sizzling and the outlook endless. Here are just a few of the event highlights, appropriately, A to Z:

A – Access to Capital is the key. No money. No honey. Capital fuels innovation and commercialization. In the first panel discussion of the day – Funding Paths for Innovators – AZBio chief Joan Koerber-Walker engaged Mary Ann Guerra (BioAccel), Paul Jackson (Integrus Capital/Worthworm) and Kelly Slone (National Venture Capital Association) in a no-holds barred discussion. “The entire ecosystem has changed,” according to Slone. “After the tech bubble burst, available venture dollars have been virtually cut in half.” Guerra explains that only one in 100 will get angel funding – and then only one in 100 will get venture funding. We need to think of new ways to help our startup entrepreneurs get funding.” Jackson urges innovators to think like investors and offers one solution with his online valuation process, Worthworm.

B – Bridging the Gap with the 21st Century Cures Initiative. “No industry has to face the challenges we face to bring a product to market,” says Koerber-Walker. “We have new hope in the 21st Century Cures Initiative. Google it. Watch the videos, See what they are doing. There is exciting stuff happening and some of it is happening in Arizona.”

C — Cure Corridor. Scottsdale’s Mayor Jim Lane shares his pride and plans for the largest concentration of bioscience businesses in the U.S., the Cure Corridor, bounded on one side by the Scottsdale Airpark on the West, and the Fountain Hills Mayo facility on the East, “a major driver of our economy, with $2½ billion in direct economic impact and $3.5 billion in indirect impact.” According to Lane, “Health and wellness are a part of Scottsdale’s identity. We should never stop asking how we can find new answers alleviate pain, restore health and improve the quality of life.”

D – Discovery. Development. Delivery. Valley Fever Solutions CEO David Larwood shared his company’s formula for achieving success in development and funding – The Five R’s:

Right drug.
Right patient.
Right safety.
Right time. (How long before we can sell it?)
Right reimbursent.

E – Epigenetics and Personalized Medicine. Start-up company INanoBio founder and CEO Bharath Takupalli, explained that the genome sequencing market is expected to grow to $10 billion by 2020. With a unique capability to combine nanotechnology and biomedicine, his company is in the lead for building new solutions now. “We aim to develop a $100 ultrafast nanopore-based desktop sequencer – a point-of-care diagnostic” that will help change the face of healthcare, he explains.

F – Funding needs to be the focus for the future. According to a Flinn Foundation/Batelle report, “Arizona has many bioscience strengths and opportunities, but a substantial increase in private and public investment will be needed over the next decade to realize the [Flinn Foundation’s] Roadmap’s goals.” Last year, Arizona bioscience sector attracted $37 million in venture capital investment, up from $23 million from 2012, but that is only a fraction of the $9.8 billion invested nationally.

The goal is to increase the annual investment up to $40 million for seed capital in emerging companies and up to $125 million in venture capital.

G – Genomic advances hold high hopes for positively disruption. Explaining that healthcare premiums are growing at three times the rate of inflation and wages, Frederic Zenhausern, Ph.D., MBA, president of Whitespace Enterprise, says “The new era of precision healthcare (also called personalized healthcare) will provide more accessibility, transparency and health information to improve – dramatically – quality and lower cost over time.” His start-up company, based in Fountain Hills, develops methods for automating and miniaturizing the workflow processing of biological specimens.

H – Henry Ford.“I am looking for a lot of men who have an infinite capacity to not know what can’t be done,” said Henry Ford. So does Robert Penny, M.D., Ph.D., co-founder and CEO of the International Genomics Consortium and founder and CEO of Paradigm. “Phoenix has become the Grand Central Station for all the aggregating and analyzing cancer tissues. We have 10,000 tumors – and the information is publicly available. This will accelerate cancer discovery at a rate faster than ever,” he says. “This is a tidal wave that Arizona has led. Everyone in this room should be grabbing a surfboard and figuring out how to ride it.”

I – IPO: The nation’s top IPO of 2013 is right here in Chandler. With 380 percent growth in shareholder value, Insys Therapeutics, a commercial-stage specialty pharmaceutical company, ended the year with a market cap of $800 million. Darryl Baker, the chief financial officer, explained how the company, founded in 2002 by Dr. John Kapoor, was determined to discover better ways to deliver existing medications to patients. A sublingual fentanyl spray technology delivers treatments to opioid-tolerant cancer patients and holds real possibilities for better helping patients with acute pain, major burns and pediatric issues. In the R&D pipeline now is the development of a pharmaceutical cannabinoid, aimed at easing epilepsy, peripheral neuropathy and cocaine addiction.

J – Jobs: 107,000 bioscience jobs – good-paying and growing. Arizona has nearly 107,000 bioscience jobs, based on 2012 industry data, and the sector contributes an estimated $36 billion in revenue to the state’s economy, according to a study by the Ohio-based Battelle Technology Partnership Practice. Hospitals account for 83,000 of those jobs and $22 billion of the revenue. Arizona’s average annual wage in the bioscience sector is $62,775, 39 percent higher than the private-sector average, the report said. Not counting hospital jobs, the average wage for bioscience jobs jumps to $85,571. (2013 data).

K – Kalos Therapeutics is building a promising platform for future drug discovery. Start-up innovator Michael Kozlowski, OD, Ph.D., chief science officer of Kalos Therapeutics, explains that their focus on transforming the atrial natriuretic family of peptides engages a natural biochemical mechanism. This approach holds promise for people with pancreatic cancer because it results in a more complete response, reduced side effects and improved safety and a longer period of effectiveness.

L – Let’s leverage every resource, strength, collaboration and person we’ve got! Arizona’s bioscience industry is aiming to increase research revenue for institutions statewide by 69 percent over the next decade to $782 million and attract additional anchors for the sector.

M – Medtronic models aggressive, needs-focused growth. Keynote speaker Ron Wilson, vice president and general manager of the Medtronic Tempe campus made it clear that passion for people runs through his veins. Locating a small manufacturing facility here in 1973, the company’s facility today covers 30 acres, has 900 employees and generates $17 billion in revenues. How do they do it? We follow our founder’s vision still: We understand what the unmet needs are and we apply our knowledge for the good of people all over the world.”

N – Next Level. “Arizona has made unprecedented progress over the last decade in developing the talent, building research infrastructure, and growing its base. Taking it to the Next Level will require new collaborative partnerships, forward looking leaders, and aggressive investments from both the public and private private sectors to take our place in the top tiers globally,” shared Koerber-Walker. ”Now is our time. Let’s get it done!”

O – Orphans no more. Valley fever, considered an orphan disease, hits about 150,000 people a year – 60 percent live in central Arizona. Current treatments have major shortcomings, with about 60 percent of those treated being unresponsive. The result is 2,000 serious cases and 150 deaths a year. It affects pets in nearly equal proportion. David Larwood, CEO of Valley Fever Solutions, has some answers. His company is developing Nikkomycin Z (NikZ) as a dramatically superior potential cure for Valley Fever. To help raise awareness and prevention, the Arizona Board of Regents created Valley Fever Corridor project, a public health program led by University of Arizona College of Medicine’s John Galgiani, MD, who is also the chief medical officer for Valley Solutions.

P – Policymakers are on board. Gov. Jan Brewer’s time is coming to a close and it’s time to decide which candidate can bring their best to bioscience. Recognizing that the Arizona bioscience sector is growing at four times the rate of the national average, candidates Christine Jones, Doug Ducey, Fred Duval, Ken Bennett and Scott Smith shared their ideas on how to ramp up funding and revenues in 90-second videos. Koerber-Walker says, “The most important thing we can do this summer is vote in the primaries.”

Q – Cues: Here are a few Q’s for success. Some lessons learned, courtesy of Robert Penny:

Make sure you have:

Complementary skills and expertise
Trust
Interpersonal chemistry (It’s better to navigate bumps in the road with people you trust than people you don’t!)

Pick the right projects:

Big enough to be worthy of your efforts
Complex enough to need partnerships
Audacious enough to move the field

R – Remembering Polio: Can Looking Back Catapult Us Forward? How did we cure the world of polio? What did it take to conquer the most feared disease of the 20th Century? What threatens our world today and how can we continue to keep people healthy with the right vaccines, for the right person at the right time? Gaspar Laca, state government affairs director at GlaxoSmithKime, engaged David Larwood, CEO and president of Valley Fever Solutions (and a person who has been directly affected by polio) and Rep. Debbie McCune Davis, executive director of The Arizona Partnership for Immunization, in a rousing discussion of what’s happening in Arizona today, the mounting threats of the ”vaccine exemptors,” and what we need to do now. (See Vaccines.)

S – Shoes. Did you see those shoes? “Give a girl the right shoes and she can conquer the world!” Enough said.

T – Tucson’s Critical Path Institute creates new tools. A jewel in the bioscience crown – and located right here in Arizona! The Critical Path Institute (C-Path) is a breakthrough organization, creating a new movement: “consensus science.” Keynoter Martha Brumfield. Ph.D, president and CEO, shared what can be achieved when people come together with the belief that a “rising tide floats all boats.” Working to improve the unacceptable 95 percent failure rate in the testing of new drug therapies, C-Path is improving medical product development efficiencies by identifying pathways that integrate new scientific advances into the regulatory review process. Check out their Alzheimer’s clinical trial simulation tool.

U – United we stand. Mayors Jim Lane (City of Scottsdale) and John Lewis (Town of Gilbert) will join Koerber-Walker and an Arizona bioscience-business contingent next week at the 2014 BIO International Convention in San Diego (June 23-26), the world’s largest biotechnology gathering. They will surely scoop up new ideas, new connections – and with any luck, new investment!

V – Vaccines: Get ‘em! Talk about ‘em. Challenge the myths. Explain the realities. Polio. Measles. And whooping cough today. Without proper vaccinations, whooping cough (pertussis) could be the polio of our time. “As science-minded people, the best thing you can do is activate conversations about the importance of vaccinations. Here’s some help: Why immunize?

W – White Hat event brings in national investors. (Apply by July 15th.) “AZBio’s White Hat Investor’s Conference is the first ever life science specific investor conference to be held in Arizona,” says Koerber-Walker. “Kelly Slone [of the National Venture Capital Association] has been an amazing partner to bring this together along with the state bioscience association leaders from across the Rocky Mountain Southwest Region. Investors and investment firms from across the country will be here, so get involved. Even if you feel like you are not ready yet, take the leap and apply to present. “

X – “X” marks the spot for our next big gathering. Wear your White Hat! The West was won by innovators, investors, and prospectors who understood the value of discovery and accepted the challenge of investing in new frontiers. Meet a new generation of biotech and healthcare pioneers at White Hat Investors 2014, the first annual biotech and healthcare investor conference that showcases the best of the Rocky Mountain & Southwest Region.

Bioindustry Associations from across the Rocky Mountain and Southwest Region are coming together to present an opportunity for Angels, Venture Capitalists and Strategic Investors to connect with the best biotech and healthcare investment opportunities from across the Rocky Mountain & Southwest states at White Hat Investors 2014 in Phoenix, Arizona on September 17 & 18, 2014.

Presenting Companies will be selected from the region’s emerging innovator leaders in the fields of:

Diagnostics
Therapeutics
Medical Devices
Health IT

Y – Young Talent is being cultivated. We got it! With nearly 50 abstracts accepted and student presenters presenting at the Expo, Koerber-Walker got it right when she said, “These young people are going to be working on things that we can’t even begin to imagine!” Arizona’s tremendous mentoring people and organizations are sharing knowledge, support and inspiration. For example University of Arizona student Keeley Brown is destined to help the world crack the code on genetically modified foods and farming. (Her presentation was the “Epigenetic Effects of Transgenic Manipulation in Glycine Max (Soybeans).

Zzzzzzzzz – No one fell asleep at this conference! Catherine Leyen, founder and CEO of start-up RadiUp, says she comes to AZBio to stay abreast of the action, connect with like-minded people and soak up inspiration. Her verdict of AZBIO Expo 2014? Mission accomplished!