Tag Archives: Linda Vocila

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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.

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TGen-TD2-Scottsdale Healthcare study benefits patients

The Side-Out Foundation’s breast cancer pilot study, led by the Translational Genomics Research Institute (TGen), Translational Drug Development (TD2) and Scottsdale Healthcare, has shown that cancer patients do better when their treatment is guided by molecular profiling.

Specifically, 52 percent of patients with advanced breast cancer received clinical benefit – meaning their disease was controlled for a longer time – when their cancer was treated based on addressing the abnormal proteins in their tumor, according to the study conducted at the Virginia G. Piper Cancer Center Clinical Trials, a partnership of Scottsdale Healthcare and TGen.

Each patient’s treatment was “personalized,” meaning that the therapy they received was based on their individual tumor biology.

“This study demonstrates the feasibility of personalized cancer treatment, and shows that this approach merits further investigation in future studies,” said Gayle Jameson, Nurse Practitioner at Scottsdale Healthcare’s Virginia G. Piper Cancer Center Clinical Trials and the study’s Principal Investigator.

“The success of this pilot study will lead to a larger study and hopefully greater clinical benefit for more patients with advanced breast cancer,” said Jameson, who presented the results of the study in June at the 2013 American Society of Clinical Oncology (ASCO) in Chicago.

Due to the overwhelmingly positive results, a new study incorporating additional technology for tumor analysis, Side-Out II, will open at the Virginia G. Piper Cancer Center Clinical Trials in the near future for patients with advanced breast cancer.

“The success of our pilot proof-of-concept study has established a firm launching pad for the upcoming Side-Out II study, which involves a more in-depth investigation of tumor biology with an expanded repertoire of tests to direct personalized treatment,” said Dr. Jasgit Sachdev, M.D., a breast cancer specialist and Associate Professor at the Virginia G. Piper Cancer Center Clinical Trials.

“By showing the significant advantages of molecular profiling, this pilot study has enabled us to move forward with a project that should strengthen the evidence for using this approach in routine clinical care.”

The recent pilot study built on previous studies by Scottsdale Healthcare and TGen that showed the value of guiding treatment based on molecular profiling, in which each patient’s tumor was analyzed for protein abnormalities that may “drive” the cancer’s growth. The results pointed investigators toward specific genetic changes that might be addressed by specific medications.

Beyond molecular profiling, the pilot study also included mapping proteomic pathways within the tumor tissue so each patient could receive a highly targeted regimen designed to impede their cancer growth.

All of the patients in the recent study had advanced breast cancer that had progressed following multiple previous chemotherapy treatments. Of the 25 patients, 13 received clinical benefit as a result of molecular profiling. For all 25 patients, the therapy selected based on their tumor analysis was different than what they would have received in their next planned treatment, if they had not participated in the study.

The Virginia G. Piper Cancer Center at Scottsdale Healthcare was the lead site in the 2-½ year pilot study. In addition, patients in the study were treated at Virginia Cancer Specialists, US Oncology, in Fairfax, Vir.; and at Evergreen Hematology & Oncology in Spokane, Wash.

Translational Drug Development (TD2), a TGen company, managed the pilot clinical trial, and will also oversee the follow-on study, Side-Out II.

“This was an exciting study for TD2,” said Linda Vocila, BSN, RN, Director of Clinical Operations at TD2 and co-author of the study. “It demonstrates that close collaboration between physicians and scientists leads to greater clinical benefit for patients with cancer.”

Two labs analyzed tissue: the Center for Applied Proteomics and Molecular Medicine (CAPMM) at George Mason University in Manassas, Vir.; and Caris Life Sciences in Phoenix.

The Side-Out Foundation of Fairfax, Vir., sponsored the study.

To participate in a clinical trial at the Virginia G. Piper Cancer Center, please contact Patient Care Coordinator Joyce Schaffer at 480-323-1339 or joschaffer@shc.org.