January 15, 2018
Democrats on the Senate Finance Committee grilled President Trump’s nominee for HHS secretary, former Eli Lilly executive Alex Azar, and attempted to tie him to price hikes of several products during his tenure as head of its U.S. business unit. Republicans once again touted his industry experience as a positive. Azar himself agreed that drug costs are too high, and listed one of his major priorities as working to reverse the incentives that drive manufacturers to raise their prices — while still ensuring discovery and innovation through well-funded clinical trials and research. The committee’s ranking member, Sen. Ron Wyden (D-Ore.), described how Lilly more than doubled the list prices for Forteo, Effient and Stratera, as well as its top-selling diabetes blockbuster Humalog, during the five years that Azar was president of Lilly USA. Wyden also cited how, nearly one year ago, Trump described pharmaceutical companies as “getting away with murder” in terms of prescription drug costs. “I don’t know that there is any drug price of a branded product that has ever gone down, from any company, on any drug in the U.S., because every incentive in this system is toward higher prices,” Azar told the committee Jan. 9. Azar also said the government should look at a more direct negotiation of lower prices under Medicare, but cautioned that a single, national formulary could end up restricting patient access.
EMA Plans to Update CNS and Cancer Guidelines in 2018
The European Medicines Agency’s working groups plan to update and publish several guidelines on clinical investigations of central nervous system diseases and cancers, with drafts expected in 2018. In oncology, a new draft guideline is expected on the use of minimal residual disease as an endpoint for multiple myeloma trials, with a draft available by the end of the first quarter 2018, and a final version by the end of the year. In addition, revisions of the EMA’s guideline for evaluating anticancer products will cover new clinical endpoints, biomarkers, interim analyses and data maturation, as well as estimands. The EMA’s oncology panel also plans to adopt an ICH question-and-answer document on nonclinical evaluation of pharmaceuticals related to the S9 guideline. The CNS guidelines, expected by the end of the year, cover treatments for migraines, depression, bipolar disorder, epilepsy, Alzheimer’s disease and dementia. In its work plan for the coming year, the EMA’s CNS working party described the documents as needing to be brought in line with recent scientific advancements. Some guidelines date back to 1998, such as the one for epilepsy, although others were last revised in 2014 and 2015. The EMA plans to hold a public workshop during its development of the epilepsy guideline, as well. However, these goals could be subject to change — especially as the EMA faces a challenging year brought on by Brexit, according to the EMA’s executive director, Guido Rasi. “Preparing for the agency’s move to Amsterdam and the United Kingdom’s withdrawal from the European Union will occupy the time of many staff members that we would rather spend on activities that make a difference to public health,” said Rasi, in an end-of-the-year message. “We will have to refocus on our core tasks and adjourn some initiatives.”
CRI, Canadian Cancer Trials Group Launch Immunotherapy Collaboration
The Cancer Research Institute and the Canadian Cancer Trials Group plan to launch new immunotherapy clinical trials as part of a global, multi-year collaboration. CRI, a U.S.-based nonprofit, plans to use its Anna-Maria Kellen Clinical Accelerator program as well as industry partnerships to organize the clinical study of combination therapies. CRI stated how basket, umbrella and adaptive clinical trial designs will be needed to efficiently evaluate permutations of the over 900 cancer immunotherapies currently in the development pipeline. The Ontario-based academic research cooperative group, CCTG, runs Phase I, II and III trials in over 80 Canadian institutions, as well as internationally, and is supported by the Canadian Cancer Society.
Survey Finds Professionals Already Experimenting withAI Applications
Interest in artificial intelligence, deep learning and natural language processing is growing, with 44 percent of surveyed life science professionals saying they’re already using or experimenting with AI in their research, according to a poll conducted by the Pistoia Alliance. Nearly 95 percent expect to see an increase in the use of machine learning in the next two years, but see access to quality clinical data and necessary technical expertise as barriers to widespread adoption. To overcome them, collaborations over data standards, benchmark sets and access will be essential. The survey, polling 374 senior professionals, found that 46 percent of AI projects currently take place in early discovery or preclinical research phases while 30 percent of natural language processing projects are used in during early-phase clinical trials. Other AI applications included clinical development and imaging analyses, as well as biomarker discovery and patient stratification. By comparison, 11 percent said they are not using AI at all, with 27 percent eschewing natural language processing and 30 percent reported no use of machine learning.