20160219 - Feb 19, 2016
ISSUE 7 – FEB. 19, 2016PDF



Should ODAC Vote? Yes? No? Undecided?

At its most recent meeting, in July 2015, the FDA Oncologic Drugs Advisory Committee voted…

No, it didn’t vote!

Breaking with a long-standing tradition, the agency asked ODAC members to “discuss” the key questions of risk vs. benefit of an experimental therapy instead of reducing their answers to a yea-or-nay vote. Agency officials are mum on the subject of whether not voting has become a thing.

News Analysis

Rejected Therapy Reveals Inconsistency of FDA Procedures for Drugs, Immunotherapies

Reform of the FDA oncology program is emerging as the immediately tangible element of the Obama administration’s moonshot program.With a modest $75 million commitment, the administration may be able to standardize the manner in which elements of modern cancer care are reviewed and approved by the regulatory agency (The Cancer Letter, Feb. 12).

As it stands, immunological and cellular cancer therapies as well as diagnostics don’t go through the same review procedures as cancer drugs and biologics.

Slamming the Door

Part IV: Nobel Laureate in Crosshairs

In early 2012, Gilman was under the impression that CPRIT was functioning smoothly.

Then, to his surprise, the first of a series of controversies surfaced.

CPRIT’s peer reviewers had evaluated 40 applications for Multi-Investigator Research Applications, the largest CPRIT grants designed to fund team science, recommending that seven of these project receive funding. This was no small undertaking. The applications described multiple projects and core facilities.

Report: Medicare Pays 340B Hospitals Less Part B Drug Reimbursement

A group advocating for the 340B Drug Discount Program examined the widely held belief that health care organizations enrolled in the controversial federal program receive significantly higher reimbursement for drugs than institutions that do not take part in the program.Previously, a July 2015 study by the Government Accountability Office found that, per beneficiary, Medicare Part B drug spending was indeed higher at 340B hospitals than at non-340B hospitals.

In Brief

  • Arnold Foundation gives $7.2 million to drug pricing programs
  • Joan Schiller named deputy director at Inova Cancer Institute
  • Jeannie Lee receives 2016 Lurie Prize
  • Canadian Cancer Society names four excellence award winnerse
  • Marcia McNutt named president of National Academy of Sciences
  • Medical Oncology & Hematology Associates of Northern Virginia joins Inova Medical Group

 

20160212 - Feb 12, 2016
ISSUE 6 – FEB. 12, 2016PDF



Obama’s $4.1 Trillion Budget Proposes Mandatory Funds for $1 Billion Moonshot

President Barack Obama Feb. 8 unveiled his budget proposal for the 2017 fiscal year—a $4.1 trillion spending blueprint that is unlikely to be passed by a Republican-controlled Congress.

The administration’s proposal appears to cut the NIH existing budget by $1 billion in discretionary funding and makes up the difference with mandatory funding.

In a joint snub, the House and Senate budget committees declined to hold a hearing for Shaun Donovan, the director of the Office of Management and Budget. The move marks the first time in 41 years that Congress has refused to review a president’s budget.

Conversation with The Cancer Letter

Sigal: FDA Should Consolidate Cancer Portfolio

President Barack Obama’s Feb. 8 budget request for fiscal year 2017 slates $75 million in additional funding for FDA for the creation of a virtual Oncology Center of Excellence.

The proposal is arguably the most tangible component of Vice President Joe Biden’s National Cancer Moonshot program, which aims to double progress in cancer research and drug development over the next five years.

Slamming the Door – How Al Gilman Taught Texas a Lesson in Science

Part III: 18,000 Bosses

Between the fall of 2011 and the spring of 2012, I watched MD Anderson from afar, and I didn’t think about CPRIT at all.

Friends who attended early meetings with Ronald DePinho soon after he became MD Anderson’s president said that he was literally grading presentations made to him by faculty members and administrators.

“This was a C-,” he would say.

It was difficult to get a B.

In Brief

  • Miami Cancer Institute joins MSK Cancer Alliance
  • Ramalingam named deputy director of Winship Cancer Institute
  • David McConkey appointed director of Johns Hopkins Bladder Institute
  • Sylvester Comprehensive Cancer Center creates two endowed chairs
  • Pat Keel appointed CFO of St. Jude
  • Paul Vanveldhuisen named COO of The Emmes Corporation
  • American Urological Association, Urology Care Foundation and Chesapeake Urology Associates form partnership
  • Bonnie J. Addario Foundation launches second phase of crowdsourcing challenge
  • ESPN’s Jimmy V Week for Cancer Research raises $3.2 million
Drugs and Targets

  • FDA grants orphan designation to tazemetostat
  • PDS Biotechnology signs CRADA with NCI
  • FDA grants orphan designation to antifungal drug candidate CD101 IV

 

20160205 - Feb 5, 2016
ISSUE 5 – FEB. 5, 2016PDF



Slamming the Door

Part II: Cancer’s Butt

CPRIT’s review process appeared to have become a major annoyance to those who wanted to redraft the criteria for dispensing the princely sum of $300 million a year. Texas geography and Texas politics did matter—a lot.

The cross-state competition between MD Anderson Cancer Center and UT Southwestern Medical Center proved to be especially important.

MD Anderson has long been a clinical powerhouse, the kind of place you go with a complicated cancer. If it ramped up its basic science, the cancer center would be better positioned to understand the origins of cancer and make more fundamental contributions to treatment of cancers, including discovering useful drug candidates and moving them from the bench to the clinic.

White House Promises $1 Billion for Cancer MoonshotThe White House announced a $1 billion initiative Feb. 1 to jumpstart the national cancer moonshot program—an ambitious proposal first announced by President Barack Obama during his final State of the Union address.

Vice President Joe Biden, whose son Beau died of brain cancer in May 2015 at age 46, is leading the program, which aims to achieve a decade’s worth of progress within the next five years.

FDA Releases New Opioid Plan as Senators Stall Robert Califf’s Confirmation as Commissioner

Robert Califf, the nominee to serve as the next FDA commissioner, and other FDA leaders called for a broad plan to reassess the agency’s approach to prescription opioid medications. The move comes as Senators block a vote on his confirmation for the top post.

Sen. Edward Markey (D-Mass.) and Democratic presidential candidate Sen. Bernie Sanders of Vermont have both placed procedural holds on Califf’s confirmation, citing the agency’s policies and methods for approving opioids, as well as Califf’s financial ties to the pharmaceutical industry.

In Brief

  • Lonial named head of hematology and oncology at Winship Cancer Institute
  • Stand Up To Cancer Canada announces brain cancer dream team
  • Keith Hanson McGregor named CEO of ESMO
  • M. Beatriz Currier joins Miami Cancer Institute
  • H. Benjamin Harvey and Courtney Moreno receive ACR fellowship
  • Van Andel Research Institute-SU2C Dream Team trial enters phase II
Drugs and Targets

  • Venetoclax receives third FDA breakthrough designation
  • FDA tells Telesta they need another phase III MCNA trial
  • Mayo Clinic collaborates with Morphotek in triple-negative breast cancer study.