New discovery may aid diagnosis
One of the worst forms of lung cancer is an adenocarcinoma that is identified by chemical changes in a normal cell communication circuit called KEAP1/NRF2. These changes also occur in another circuit, PBK. The 20 percent of tumors that display these changes are found most often in women and teenagers, reported Arlene Weintraub in Fierce Biotech.
Accountable for Opioids?
While the majority of shareholders of AmerisourceBergen (ABC), the large Philadelphia-based drug wholesaler, rejected a proposal last Thursday that would have forced the company to “report steps taken to manage the financial and reputational risks associated with the opioid crisis,” the proposal did have the support of many independent shareholders, according to an article by Ed Silverman in Pharmalot.
“Yesterday’s triumphs may pale beside the promise of tomorrow’s breakthroughs — if pressures on research funding don’t threaten the future of biomedical research,” said researchers Jeffrey A. Bluestone, David Beier and Laurie H. Glimcher in an article called “The NIH is in danger of losing its edge in creating biomedical innovations” in STAT.
Scrutiny for Sponsors
There are consequences when clinical trial sponsors fail to report study results on time to clinicaltrials.gov. A new online tracker developed by the clinical trial transparency advocacy project AllTrials publicly shames these sponsors by putting them under public scrutiny,
Better Than Expected
A study published in the journal Biostatistics recently offers good news for pharma. Not only is the approval rate for drugs that go through clinical trials higher than anticipated (14 percent), but it is trending upward since 2013, according to researchers at the Massachusetts Institute of Technology (MIT). The study, which covered the period from 2000 to 2015, indicated that approval rates were lower between 2005 and 2013, but “have been trending upward since then,” according to an article by Ben Adams in Fierce Biotech.
A new round of funding will give XtalPi, a computation-driven Chinese startup, a chance to provide applications of artificial intelligence for drug research and development. Leading the charge in the $15 million series B round of finance are high-profile technology investors Sequoia China, Google and Chinese internet giant Tencent, according to an article by Angus Liu in Fierce Biotech.
The huge amounts of data created in clinical trials make it increasingly hard to share the information safely, keep it from being compromised, protect subject privacy and increase subject recruitment.
Efficient Data Acquisition
Will new technologies be able to break down the barriers to genome sequencing for large numbers of people? George Church, described in an article by Nick Paul Taylor in Fierce Biotech as a “prolific startup creator,” thinks so.
The major drug manufacturer Novartis intends to expand its use of the Apple Research Kit (ARK) software in its clinical trials, according to Andrew McConaghie, writing in Pharma Phorum. This could increase the involvement of digital technology in all drug research and development.
Three very large companies, Berkshire Hathaway, Amazon and JPMorgan Chase bank, have agreed to jointly address the costs of prescription drugs for their combined 1.1 million employees, reported Ben Popken and Lucy Bayly on NBC News. The partners will create a new company to provide drugs “…at a reasonable cost.” An event of this size could have an impact on all of medical economics.
Apple is providing easy access to complete medical records
The inability of medical providers to share data has been called the interoperability crisis” and has a harmful impact on care. Patients’ data often exists as PDF files connected to e-mails, which inturn are only reachable through “patient portals,” which can be incomplete and not open to all providers.
In an effort to reduce the number of patients needing to receive placebos in clinical trials and to lower overall costs, the U.S. Food & Drug Administration (FDA) has come up with a draft proposal that shows how drug developers targeting rare pediatric diseases can form collaborations to “streamline their clinical development programs.” According to an article by Nick Paul Taylor in Fierce Biotech, FDA officials would like for drug developers to think about joining forces to run tests on multiple candidates in single trials.
Since cancer is defined as fast and unregulated cell growth, stopping it by destroying an enzyme that supports cell division represents an exciting new approach to fighting cancer, reports Amirah Al Idrus in Fierce Biotech.
Information about clinical trials is often not available for potential subjects, or else is irrelevant to their particular cases or their level of education.
Now that QuintilesIMS became IQVIA after the megamerger, INC Research/inVentiv Health decided that it had to follow suit in its own megamerger. The latter has now been rebranded as Syneos Health four months after the completion of the $7.4 billion merger.
Major companies have invested in a $58 million financing round for DNAnexus, a California-based genomics platform firm that offers a worldwide network for sharing and management of genomic data and tools to expedite genomics research. Directed by the healthcare-focused investment firm Foresite Capital, the funding included strategic investment from Microsoft, Alphabet’s investment arm GV (formerly Google Ventures) and Wuxi, reports Angus Liu in Fierce Biotech.
Worker shortages, uneven performance top list
Despite the many advances in instrumentation and procedures, the clinical research sector still faces a major hurdle, reports Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP), on the website www.outsourcing-pharma.com: both a shortage of workers in several categories including investigators, coordinators and site monitors, and the uneven performance and variability among research personnel. In the article, “A turning point: Examining the clinical research workforce in 2018,” he makes a case for bringing more people into the workforce and imbuing them with the appropriate skills to succeed.
Clinical researchers have to balance increasing demands on their time with maintaining a patient-centered approach. Sometimes, professional standards are not meeting the reality of the positions.