Life Sciences Law & Industry Report connects the dots among the many disciplines that make up the burgeoning life sciences industry, with biweekly updates on current regulatory, legislative,...
June 29 — The cancer “moonshot” initiative will establish programs to expedite both the medical and patent reviews of new cancer treatments within federal agencies, the White House announced June 29.
The new efforts are just two of nearly 40 programs that the Obama administration announced to support the cancer initiative being led by Vice President Joe Biden. The announcement includes both government collaborations such as using the computing power at the Department of Energy to advance research at the National Cancer Institute—part of the National Institutes of Health—along with private sector partnerships with companies such as IBM, GlaxoSmithKline and Deloitte Consulting LLP.
“The goal of the moonshot is to propel us forward today,” Biden said at the Howard Universitysummit in Washington, one of 260 such events that took place concurrently across the U.S. “I believe we can make exponential progress. I firmly believe we can do it in the next five years when it would ordinarily take 10.”
Biden expressed concern about the rising cost of drugs. “The costs of lifesaving drugs are astronomical,” he said. “We have to call for a better way. What is the possible justification, when a lifesaving drug is brought to market, it costs $26,000 a year and 15 years later it costs $120,000?”
Greg Simon, executive director of the White House Cancer Moonshot Task Force, said the new programs stem from challenges that Biden has identified in the way the nation approaches cancer.
“Some of those challenges are systemic in the way we give out grant money, the way we reward publication, the way that we reward people with tenure for certain things that are not related to patient care rather than those that are related to patient care,” Simon said in a call with reporters before the summit. Delays in many aspects of this approach could be addressed by a change of culture, he said.
The partnerships announced in conjunction with the summit represent a “down payment,” Simon said, on actions that can be achieved this year.
“I think of the summit as a pivot from what we have done from the first three months to what we’ll do the rest of the year,” Simon, who took on his new White House role in mid-March, told reporters (10 LSLR 07, 4/1/16).
“The summit marks the beginning of a new discussion with the private sector and the nonprofit and the government about how to make sure we can really involve collaborations that involve system change in the way we approach cancer.”
The private sector collaborations include a partnership between IBM and the Department of Veterans Affairs to provide precision medicine options for veterans who are cancer patients, an XPRIZE innovator award sponsored by Deloitte and an Oncology Precision Network designed to improve the sharing of cancer genomics data.
When President Barack Obama tapped Biden to lead the initiative, the vice president said he was given authority over every Cabinet agency that has any possible impact in the fight against cancer.
A new Oncology Center of Excellence at the Food and Drug Administration, one of the projects announced at the summit, is designed to streamline regulatory reviews of new medical products to treat cancer by improving coordination among the agency's drug, device and biologic centers.
Richard Pazdur, the acting director of the new center, wrote in a June 28 blog that he will implement a “staged approach for establishing the new center while ensuring the work across centers continues without disruption.”
“The OCE emulates both academia and cancer care centers, which are increasingly organized in multidisciplinary models to enhance collaboration, which is so essential when confronting a complex disease like cancer,” Pazdur wrote.
The Patent and Trademark Office also announced a new program to fast-track patent applications for new cancer therapies, cutting the agency's review time in half, to fewer than 12 months (10 LSLR 14, 7/8/16).
The NIH also announced a number of programs as part of the summit, including an initiative to make it easier for patients and caregivers to find out about the latest oncology clinical studies. The NIH also is using the supercomputing capabilities at the DOE to analyze preclinical data models, along with a separate effort with Energy and GlaxoSmithKline to accelerate the drug discovery process and bring new cancer therapies to first-in-human trials in under one year.
During the summit, Biden reiterated the need for systemic and cultural changes, including changing research systems at the NIH. He raised concerns that NIH-funded scientists aren't complying with a 2007 law to submit their reporting results.
“Under the law, it says you must report. If you don’t report, the law says you shouldn’t get any funding,” Biden said. “I’m going to find out if it it’s true, and if it’s true I’m going to cut funding. That’s a promise. That’s a promise because all it does is slow progress.”
Bloomberg Philanthropies provides financial support for the moonshot initiative.
To contact the reporter on this story: Jeannie Baumann in Washington email@example.com
To contact the editor responsible for this story: Randy Kubetin firstname.lastname@example.org
A White House fact sheet with details about the partnerships is at https://www.whitehouse.gov/the-press-office/2016/06/28/fact-sheet-cancer-moonshot-summit-vice-president-biden-announces-new.
Copyright © 2016 The Bureau of National Affairs, Inc. All Rights Reserved.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to email@example.com.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to firstname.lastname@example.org.
Put me on standing order
Notify me when new releases are available (no standing order will be created)