2
Dec

DNA sequencing is changing the oncology clinical trial space

dna A paradigm shift is taking place in the oncology clinical trial space, partially as a result of the Obama Administration launching its “Precision Medicine Initiative” earlier this year. Precision medicine is an innovative approach that takes into account individual differences in people’s genes, environments, and lifestyles.

According to a White House release, a $215 million investment in the President’s 2016 Budget will be allocated to the Precision Medicine Initiative to pioneer this research and provide clinicians with new tools, knowledge and therapies to select the treatments that work best for their patients. The funding will be spread out between the National Institutes of Health (NIH), the Food and Drug Administration (FDA) and the Office of the National Coordinator for Health Information Technology (ONC).

The objective for the National Cancer Institute is to accelerate the design and testing of tailored treatments for cancer by expanding genetically based clinical cancer trials. In June of this year, the NCI announced the launch of its nationwide clinical trial, utilizing DNA sequencing. In other words, subjects are grouped based on similarity in their genetic mutations, not the location of their cancer. The grouping is also known as “basket trials”. In the study, a few thousand patients at 2,400 sites throughout the United States will be sorted out into over a dozen treatments based on their tumor’s mutation.

The American Society of Clinical Oncology also recently announced the launch of a project that will provide patients with drugs targeting similar molecular abnormalities, and collect the data from their oncologists in order to monitor the effectiveness of the treatments.

The National Institutes of Health (NIH), in collaboration with other agencies and stakeholders, will launch a national, patient-powered research cohort of over a million Americans who volunteer to participate in research. The trial subjects will be involved in the design of the Initiative and will have the opportunity to contribute various data—including medical records; profiles of the patient’s genes, metabolites (chemical makeup), and microorganisms in and on the body; environmental and lifestyle data; patient-generated information; and personal device and sensor data.

The Initiative will include reviewing the current regulatory landscape to determine whether changes are needed to support the development of this new research and care model, including its privacy protection framework. As part of this effort, the FDA will develop a new approach for evaluating Next Generation Sequencing technologies — tests that rapidly sequence large segments of a person’s DNA, or even their entire genome.

2
Jun

Higher Cost IV Drugs Not Addressed by ASCO Payment Proposal

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The American Society of Clinical Oncology (ASCO) made payments for oncology care a central focus of their meeting this week. In their paper released in May 2014 the ASCO Payment Reform Workgroup suggests a new payment scheme for oncology care. Oncology practices would receive five types of flexible, bundled payments designed to cover currently uncompensated time and costs in addition to services currently reimbursed. Currently, practices get reimbursed for patientface time with the physician and drug infusions but not for a lot of services now important in cancer therapy, such as, time spent with nurses, other staff like nutritionists needed for patient education or treatment planning.
The five proposed new payments include:

· Payment for new patient—higher than currently provided for initial visit
· Treatment month payment—set at 4 different levels depending on severity of patient condition and required supportive services. It would delete cost of drug infusion but cost of drugs would be still covered but separately.
· Active monitoring month payment—for care and support after medication therapy ends, such as, disease monitoring for recurrence or progression of disease.
· Transition of treatment payment—for treatment planning and patient education when treatment needs to be changed.
· Clinical trial payment—payment for services of physicians in providing clinical trial access and support.

The proposed additional new payments are supposed to provide improved care and value for the patient. The problem I see with the above is that the wording suggests lots of different interpretation in the “coding” involved in each of the five payments. They are too vague, not easily measurable and subject to upward slippage in cost. See full report here.

The real kicker in this proposal is the following: “In addition to the five consolidated payments, the practice would continue to receive separate payments for tests and major procedures it performs and reimbursement for the costs of purchasing and storing drugs the practice administers in the office.” I see real problem with double payments for services in their scheme.

In article entitled “Reforming Oncology” in the June 2, 2014 issue of BioCentury Senior Editor Erin McCallister says ASCO’s “newly unveiled payment model doesn’t yet address how physician practices actually should be paid for drugs. He goes on to remind us the ASCO approach does nothing to address the “elephant” in the room–the use of higher cost IV drugs vs. oral drugs to boost revenues. “Instead, payers are the ones taking the lead on new models that remove or lessen incentives to prescribe IV drugs to boost oncologist profits.” This thorough article discusses the new approaches of payers like Wellpoint and United Health that tackle this real problem which needs addressing.

You can find the complete list of events included in Audrey’s Picks with full details and the latest list of Jobs that Crossed My Desk in the attachments or on my blog found at www.Audreysnetwork.com.

Audrey

Reposted from Audrey Erbes’ blog: Audrey’s Network

Audrey’s Network includes Bay Area bioscience professionals from all sectors who are working in broad array of functions in the industry. The group originated, first, with members sourced from Audrey’s UC Extension intensive courses in Bioscience Business and Marketing (now numbering over former 1,250 students), the Syntex Syva Alumni Association, the Bio2Device Group (now has over 1,000 members) and other industry professional groups and individuals with whom Audrey has worked. The mission is to assist industry professionals continue to keep up-to-date in their fields through “sharpening the saw” regularly and building and maintaining a vibrant network.

24
Mar

Tribute to A Brave Patient, by Audrey Erbes

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This week I want to pay tribute to John “Jay” Geddes Erbes who despite living a productive life filled with good diet and  exercise from all manner of sports passed as a result of malignant Stage IV glioblastoma for which our industry has found no cure. After five months of enduring an initial attempt to remove the aggressive tumor with a craniotomy and then receiving the highly toxic medications included in the guideline therapy for this aggressive cancer of the brain, he died of an apparent side effect from a biologic drug.

We were fortunate and grateful to have had the outstanding expertise and excellent patient care by the team of physicians and nurses at UCSF and the surgery performed by a Palo Alto Medical Foundation neurosurgeon trained at UCSF. El Camino Hospital in Mountain View was an outstanding center of surgical care as well as care of the families of the patients. We learned that those in our geographic area are truly blessed with outstanding medical access.

Jay was a valiant patient and never gave up. Our current healthcare expertise failed him and spurs me on to support investment in innovation in oncology. He carried around a cell phone with both a video of his winning a foot race in Olympia, Greece in July and an MRI film of his tumor only partially removed in August. He told folks that he had fulfilled his bucket list and got in his one final wish for a “jog” at Pismo Beach on the Central Coast on Jan. 14th, when we experienced an unusually hot week prior to his sudden and unexpected death from a drug side effect. We need to continue the pursuit of more efficacious therapy with less adverse reactions.

Reposted from Audrey Erbes’ blog: Audrey’s Network

Audrey’s Network includes Bay Area bioscience professionals from all sectors who are working in broad array of functions in the industry. The group originated, first, with members sourced from Audrey’s UC Extension intensive courses in Bioscience Business and Marketing (now numbering over former 1,250 students), the Syntex Syva Alumni Association, the Bio2Device Group (now has over 1,000 members) and other industry professional groups and individuals with whom Audrey has worked. The mission is to assist industry professionals continue to keep up-to-date in their fields through “sharpening the saw” regularly and building and maintaining a vibrant network.

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