Firm to aid small practices’ clinical trials
Arizona hospitals have committed more than $400 million on new cancer centers and technology in an effort to bring the most sophisticated treatment to patients.
While larger centers such as Banner MD Anderson Cancer Center and Mayo Clinic have the financial wherewithal to make large investments to woo patients, smaller physician practices that treat cancer patients don’t have comparable resources.
But now some oncologists are seeking to secure their own place in metro Phoenix’s increasingly competitive cancer-care market. They are aligning with a company that is recruiting a network of doctors who are willing to offer experimental cancer drugs and therapies to their patients.
The arrangement gives physicians and their patients access to experimental drugs through clinical trials. It also allows pharmaceutical companies a network of physicians who can administer these drugs to patients in clinical trials, which are required before the Federal Drug Administration will approve a drug for the general public.
Translational Research Management, founded by Christopher Beardmore with seed funding from biotech billionaire Patrick Soon-Shiong, seeks to ease the administrative burden of community oncologists who want to offer clinical trials to patients.
Clinical trials historically have been the territory of academic medical centers such as the University of Arizona Cancer Center, which have government-funded budgets and a roster of experienced physicians and scientists, protocols and administrative support. But private-sector organizations that tout speed and efficiency at managing clinical trials are taking a larger role in both early- and late-stage clinical trials.
While some academics question the scientific benefits of pharmaceutical-industry-funded trials at for-profit sites, the clinical-trial sites say the speed and flexibility they offer is invaluable, particularly as drug development has grown more complex in the era of genomics-based medicine.
Beardmore and physicians who oversee the clinical trials say patients ultimately benefit by getting access to experimental therapies more quickly.
“The only way we are going to get personalized medicine is to get these practitioners involved,” Beardmore said of his efforts to recruit like-minded physicians. “I will take anybody who really believes that clinical-trial participation improves outcomes. If they do, then I will accommodate them, support them and make it happen.”
A support network
Los Angeles-based Translational Research Management provides administrative and regulatory support for a network of medical, radiation and surgical oncologists, known collectively as the Arizona Cancer Research Alliance. So far, the alliance has recruited about 31 doctors and practitioners who are involved in cancer care in metro Phoenix.
Small-physician practices face many barriers to participate in clinical trials. Most small practices don’t have the time or budget to get involved, because there are have strict legal and regulatory rules.
Many community oncologists face additional financial pressures from declining reimbursement from government and private insurance companies and competition from hospital-based cancer centers. Washington, D.C.-based Community Oncology Alliance issued a report last month that showed 241 cancer clinics have closed over the past year, including five in Arizona.
Beardmore said his company handles the business functions of small practices to allow doctors to concentrate on patients. It negotiates contracts, sets budgets and manages billing and collection on behalf of the physicians.
“We take the administrative burden out of participating in research and allow these physicians to focus on the medical aspects of their clinical practice and research,” Beardmore said.
Pharmaceutical companies pay physicians and their staff for enrolling patients in the clinical trials. A physician, for example, receives compensation for screening a patient or conducting a CT scan. The physician’s practice also is reimbursed for coordinating a study and managing data.
Translational Research Management receives a percentage of the amount that pharmaceutical companies pay participating physicians.
Doctors who have joined the network include Steven Finkelstein, a radiation oncologist with 21st Century Oncology, and Michael Gordon, a Scottsdale medical oncologist and CEO of Scottsdale-based Pinnacle Oncology Hematology.
Gordon for years has offered “phase one” clinical trials for cancer patients in metro Phoenix. Phase-one trials, also known as first-in-human trials, are designed to test the safety and toxicity of drugs in humans. If drugs are determined to be safe at specific doses, they can be studied in larger trials that test how effective the drugs are at fighting a disease or condition.
Gordon said many doctors are reluctant to offer clinical trials due to the regulatory and compliance requirements.
A typical phase-one clinical trial for a cancer drug cost about $18,833 per patient in 2008, more expensive than comparable drug trials for such medical conditions as cardiovascular disease and dermatology, according to Cutting Edge Information, a Durham, N.C.-based biotech consultant.
With drug companies paying trial costs and Translational Research Management handling administrative details, Gordon said he expects more doctors will take part.
As cancer patients become more sophisticated and seek out cutting-edge treatment, some oncologists recognize that their involvement may give them access to more clients in metro Phoenix’s competitive cancer-care market.
Gordon said that clinical sites run by private groups such as Pinnacle Oncology have an advantage in speed. These sites are able to get clinical trials started more quickly than academic centers, thus getting the experimental drugs to patients and benefiting pharmaceutical companies that want to quickly test their drugs.
“Our motivation is to translate our success to benefit many patients in our community, region and state,” Gordon said. “I would love to be able to take the drugs I am developing and translate them into broader access for our Arizona patients.”
Dr. Devinder Singh, of the Arizona Center for Cancer Care, joined the research alliance to give his patients access to the latest cancer drugs and treatments. The Arizona Center for Cancer Care has locations in Glendale, Avondale, Surprise, Wickenburg and a radiation center in Peoria.
Singh’s group now has six active clinical trials for lung- and colon-cancer patients and another recently closed trial for pancreatic cancer.
He said it is important that community centers offer trials because they will reach more patients, rather than sending patients to larger hospitals in downtown Phoenix, Tucson or Scottsdale. This will allow physicians to test targeted therapies on patients with specific genetic mutations.
“The new drugs are becoming more targeted,” Singh said. “It is important we go through the community level. That is the only way we will reach a significant number (of patients) to make a dent in the community.”
Academic centers
As some private physicians are increasingly conducting clinical trials funded by drug companies, academic centers such as the University of Arizona Cancer Center focus on a different mission.
The Arizona Cancer Center is funded with a core grant from the National Cancer Institute and receives other government-supported grants. The cancer center has an annual budget of about $4 million and a staff of nearly 50 who craft budgets, conduct scientific review and provide clinical, nursing and pharmaceutical services.
The larger budgets of academic cancer centers allow them to pursue more ambitious, expensive studies that could yield discoveries that can significantly extend lives by preventing or treating cancer, according to Dr. Michael Bookman, director of clinical research at the Arizona Cancer Center.
The pharmaceutical companies may be motivated to study drugs that can achieve FDA approval, even if those drugs offer limited value for patients.
“A (pharmaceutical) company is more willing to spend resources on a trial if they are more likely to get it to the FDA” for approval, Bookman said. “Getting a few more weeks of progression-free survival is not as meaningful to patients as extending life for years or a curative treatment.”
Though academic centers can compete with private-sector practices to host clinical trials, Bookman said he believes there is room for both approaches.
He said Beardmore’s approach of providing administrative support for community oncologists may work well in metro Phoenix, where patients can choose from the likes of Banner MD Anderson Cancer Center, the Mayo Clinic, Cancer Treatment Centers of America and Scottsdale Healthcare’s Virginia G. Piper Cancer Center Clinical Trials, which does phase-one trials through an alliance with TGen (Translational Genomics Research Institute).
“There are a lot of things happening in Phoenix right now,” Bookman said.
There is evidence of the competition among cancer centers. Banner MD Anderson, Mayo Clinic and Cancer Treatment Centers of America have advertised to attract patients.
Dr. Edgardo Rivera, medical director of Banner MD Anderson Cancer Center, said the Gilbert center has started its first brain-cancer clinical trial and has 10 more studies planned.
Rivera acknowledged that metro Phoenix cancer patients have many options, but he said competitive factors will not sway Banner MD Anderson’s approach to clinical trials.
Rivera said Banner MD Anderson will partner with pharmaceutical companies, but he said the trials need to have potential to make a meaningful difference for patients.
“If the motivation is to offer something for the patient, that is a real value and very appropriate to do,” Rivera said. “If this is just sort of a knee-jerk reaction, I will tell you the motivation is not the right motivation.”
Beardmore said that there is room for both academic centers and community oncologists due to the increasingly complex nature of cancer care. He expects both will thrive, and patients ultimately will benefit.
“Our goal is to make sure these patients have these (treatments) available at their bedside,” Beardmore said.
Chris Nowinski to receive First Annual Conquering Concussions “Hero” Award from The CACTIS Foundation
PHOENIX, AZ, January 19, 2012 – The CACTIS Foundation announced today that Chris Nowinski will receive the First Annual Conquering Concussions “Hero” Award, for his pioneering efforts in raising awareness and exploring the issue of minimal Traumatic Brain Injury (mTBI), especially in young athletes.
Nowinski is the co‐founder and president of the Sports Legacy Institute, a non‐profit organization dedicated to solve the sports concussion crisis. A former Harvard football player and WWE professional wrestler, Nowinski was forced to retire from a series of concussions in 2003. His challenging recovery from post‐concussion syndrome led him to write the book Head Games: Football’s Concussion Crisis, published in 2006, in an effort to educate parents, coaches, and children about this previously hidden public health issue.
“Chris has worked tirelessly to bring awareness to an issue threatening the health and well‐being of all athletes,” said Dr. Hirsch Handmaker, Chairman and CEO of The CACTIS Foundation. “His high‐profile campaign to educate athletes, ATCs, coaches and other medical professionals about this serious condition not only will save lives but helps raise this topic to the national consciousness and is changing how traumatic brain injuries are monitored and managed.”
The Conquering Concussion’s “Hero” Award will be presented at a banquet to be held on Friday night, March 16, 2012 to benefit the Boys and Girls Club of Greater Scottsdale. The banquet will kick off the Second Annual “Current Topics in Sports Medicine” symposium at the Hotel Valley Ho in Scottsdale, Arizona.
The all day course features 4 hours on Saturday morning, March 17, 2012, devoted to fast breaking concussion‐related topics, including testing, education, research, legislation and management of the athlete with mTBI. The afternoon presents lectures on the Throwing Shoulder, Hip Injuries in Athletes, and the scientific evidence for Platelet Rich Platelet Therapy (PRP). Dr. Lewis Yocum of the Kerlan‐Jobe Orthopaedics Clinic again will be the Guest Moderator for all sessions.
The Conquering Concussions program is being championed by The CACTIS Foundation to bring the long‐term consequences of repetitive head injury from contact sports and military service to light, with a major emphasis on education programs for 6‐14 year old athletes ‐ the most vulnerable population ‐ on a national and grass roots level.
CACTIS is collaborating with Barrow Neurological Institute (BNI), Phoenix, Arizona in extending the Brainbook e‐learning program to an age‐appropriate Junior Brainbook for younger athletes, and is piloting this program with the Boys and Girls Club of Greater Scottsdale.
Expanding this program to target those most vulnerable for complications from concussions will be undertaken by The CACTIS Foundation and the original developers to apply what has been learned from enrollment in Brainbook by over 80,000 Arizona high school athletes (out of 100,00) through the Arizona Interscholastic Association.
A rollout on a national basis for this much‐needed program will be based on the thoughtful and considerate donations of generous sponsors. Corporate and individual sponsors and donors eager to support this worthwhile effort can contact The CACTIS Foundation at (480) 383-8402 or info@cactisfoundation.org.
The CACTIS Foundation’s Game-Changing Informatics Initiative Sponsored
By Varian Medical Systems
PHOENIX, AZ – (November 26, 2011) The CACTIS Foundation today announced that a grant from the Varian Medical Systems Foundation will make it possible for CACTIS to improve the health and wellbeing of patients, especially underserved communities, in the greater Metropolitan Phoenix, Arizona area.
The grant will allow CACTIS to provide input and pilot robust and user-friendly enhancements and integrations utilizing Varian’s ARIA® electronic health record system. It will also facilitate, and the collection of uniform patient information for subsequent mining of the anonymized data for analyzing the comparative effectiveness of standard therapies, as well as early and later stage clinical trials.
“This program addresses a major unmet need in the practice of oncology, that of increasing efficiency and accountability,” said Michael Gordon, M.D., President and CEO of Pinnacle Oncology Hematology in Scottsdale, Arizona.
“These data are critically needed to improve cancer patient management and to create and comply with ‘Best Practices’ standards of care. CACTIS is committed to increasing the awareness and availability of personal medicine through Imagenomics (“molecular fingerprinting”), data collection and their effects on clinical outcomes in diverse ethnic groups,” said Dr. Michael Gordon, M.D., President and CEO of Pinnacle
Oncology Hematology in Scottsdale, Arizona.
“These data are critically needed to improve cancer patient management and to create and comply with ‘Best Practices’ standards of care. CACTIS is committed to increasing the awareness and availability of personal medicine through Imagenomics (“molecular fingerprinting”), data collection and their effects on clinical outcomes in diverse ethnic groups,” said Dr. Hirsch Handmaker, CACTIS chairman and CEO. “The speed and convenience of interspecialty consultations and communications, availability of lab reports and immediate image availability will facilitate many obvious and needed positive benefits in the practice of oncology.”
“Varian is pleased to promote and nurture the collaborative interface between a substantial community network of area physicians and providers who care for over 4.5 million people, including an estimated 500,000 underserved persons in Arizona,” said Chris Toth, Varian Medical Systems Senior Director, Oncology Marketing. “The development and implementation of enhanced software based on the input of the CACTIS community in this large and diverse population will allow for that.”
About The CACTIS Foundation
The Central Arizona Center for Therapeutic and Imaging Services Foundation (CACTIS), a 501 (c) 3 organization, is a community-based institution focused on advancing the diagnosis, treatment and prevention of disease. It accomplishes this by supporting research-oriented preclinical and early phase clinical trials and Continuing Medical Education (CME) and other programs for patients and healthcare professionals. CACTIS is currently developing programs in the fields of oncology, molecular imaging, orthopaedics and sports medicine, with significant attention to addressing the healthcare delivery disparities of underserved communities. For more information, visit www.cactisfoundation.org
FOR IMMEDIATE RELEASE
Contact:
Sally Chambers, (602) 763-5545
sally@cactisfoundation.org