All in emerging technologies
In an article in Forbes, healthcare contributing writer Standish Fleming dissected the theories of blogger Kelvin Stott in his recent posts, “Pharma’s broken business model, An industry on the brink of terminal decline.” Stott thinks technology can solve pharma’s problems, while Fleming thinks “but the solution to the innovation crisis, if there is one, lies not in technology but a new business model.”
First of all, Fleming points to the decline in productivity in pharma, which could reach a no-profit status by 2020. According to Fleming, Stott “diagnoses the problem as a failure of technology and so looks for a science-based solution to the innovation crisis. What he finds provides no way out of the dilemma.”
While the drug testing is real, the recruitment, the screening and the venue are changing the way clinical trials are conducted, reported an article by Barbara Mandark in Undark and reprinted by Fast Company.
Alzheimer’s is a “devastating memory-wasting disease that has continually seen failure after failure in the clinic,” according to an article by Ben Adams in Fierce Biotech. With no cure yet in sight, a medical technology company in Florida has taken a new approach to simulating a human with the condition.
Hesperos, an Orlando-based company that to characterize an individual’s biology with human-on-a-chip microfluidic systems, has garnered National Institutes of Health (NIH) funding for Alzheimer’s “human-on-a-chip” trials. The company received a phase 1 grant from the National Institute on Aging in order to “realistically mimic the biology of Alzheimer’s disease (AD), and the effects of potential new therapies under realistic human physiological conditions,” NIH said.
It looks like the end is near for a beleaguered Silicon Valley company. The move comes after a failed attempt by the company to sell itself, during which it reached out to more than 80 potential buyers through Jefferies Group.
Theranos, a blood-testing company embroiled in federal fraud charges against its founder and its COO, is formally dissolving, according to a story in The Wall Street Journal. The company sent an e-mail to shareholders explaining its dissolution and plan to pay out its remaining cash to creditors. The e mail from Chief Executive David Taylor also explained, “Unfortunately, none of those leads to buyers has materialized into a transaction. We are now out of time.” The letter was published by the WSJ.
AI and Aging
Developing medicines to combat aging-related diseases will be the focus od three organizations in a joint venture, according to an article by Conor Hale in Fierce Biotech. Hale recently reported that Insilico, Juvenescence and the Buck Institute were forming an artificial intelligence (AI)-based venture to expedite drug discovery as it applies to metabolism and aging-related diseases. It seems that the bottom line is only part of the story.
Clinical trials, research studies performed on humans, are designed to gain specific information about biomedical interventions such as vaccines, treatments and drugs in order to prove the safety and efficacy of the products.
Dr. Scott Gottlieb, who became the 23rd Commissioner of the Food and Drug Agency (FDA) on May 11, 2017, is proposing “to flatten out FDA’s structure by having the Center directors report directly to him, instead of through a level of “directorates” between the commissioner and Center staff,” as reported by Jill Wechsle of Pharmaceutical Executive. The objective is “to give more authority to the agency’s six product regulatory Centers and to the Office of Regulatory Affairs (ORA) and will ensure that the commissioner remains in close contact with the Center leadership,” according to Gottlieb in an email to FDA staff this week.
Biopharma in China
The sophistication of drug production in China has come a long way in a short time, offering both opportunities and challenges for Chinese and Western pharma and biotech companies, according to an article by Peter Young in Pharmaceutical Executive. In recent memory, China was “principally a low cost, low quality producer of pharmaceutical intermediates and fine chemicals,” according to Young, but the country cleaned up its manufacturing practices, developed more sophisticated medicines, conducted clinical trials, improved its regulatory system and developed “a more diversified, modern system of providing patient care.”
Early and Effective
After his wife died of colon cancer at 36 in 2014, Billy Boyle, 39, became a man on a mission. Boyle, who had been doing research on how volatile organic compounds (VOCs) could be used to diagnose complications from chemical warfare, applied the idea to a breath test that could detect cancer-linked chemicals at very early stages.
An analysis published this week by L. A. Hechtman et al. in Proceedings of the National Academy of Sciences shows that the career trajectory of women scientists is nearly as long as that of their male counterparts, once they attain a US National Institutes of Health (NIH) grant. The story, reported in Nature News by Holly Else, indicates that women are nearly as successful as men at garnering additional awards from the agency.
Predicting Progression of Alzheimer’s
Alzheimer’s disease, the sixth leading cause of death in the US, kills more senior citizens than breast cancer and prostate cancer combined. The disease affects millions of people annually, says the Alzheimer’s Association. If diagnosed early, as much as $7.9 trillion in medical and care costs could be saved, according to an article by Kyle Wiggers in Venture Beat.
CRISPR Combats Cancer
Recently, Gilead’s Yescarta and Novartis’ Kymriah took healthy immune-boosting T cells from patients and engineered them to recognize and destroy cancer. Now researchers at Brigham and Women's Hospital are creating cells that kill cancer by modifying tumor cells instead of T cells, according to Arlene Weintraub in Fierce Biotech.
Silent on Sexism?
Sen. Patty Murray, D-Wash., the top Democrat on the Senate Health, Education, Labor and Pensions Committee, is furious. After an industry party that objectified women, Murray sent letters to the Biotechnology Innovation Organization (BIO) and the Pharmaceutical Research and Manufacturers of America (PhRMA) about their efforts to combat workplace harassment at their member companies, according to an article by Amirah Al Idrus in Fierce Biotech.
Leading the Way with Strategic Partnerships
Frost & Sullivan, which analyzes markets to help investors, corporate leaders and governments navigate economic changes and identify disruptive technologies and companies, as well as Mega Trends and new business models, predicts that data monetization, direct-to-consumer and eCommerce business models will create growth opportunities in life sciences.
Ziopharm Oncology, a Boston-based biotechnology company focused on the development of immunotherapies using gene- and cell-based therapies to treat patients with cancer, believes that its point-of-care CAR-T production technology will eliminate the complex, expensive supply chain and facilities needed to manufacture first-generation therapies from Gilead and Novartis. “Instead of shipping cells from hospitals to production plants and back again, all processing will take place within two days at the healthcare center, thereby driving down treatment costs,” reported Nick Paul Taylor of Fierce Biotech.
Nameless but in the News
The new health care company launched by Amazon, Berkshire Hathaway, and JPMorgan Chase continues to remain nameless, but now it has a prominent CEO. On Wednesday the companies announced that Dr. Atul Gawande, a surgeon at Brigham and Women’s Hospital in Boston who teaches at Harvard’s medical and public health schools, will become the chief executive officer of the new organization July 9, reported Andrew Joseph in STAT.
Right to Try
Giving a measure of hope to people with serious illnesses, President Donald Trump signed the "Right to Try Act" at the end of May. The measure would enable terminally ill patients to gain access to drug treatments that are not yet completely approved by the Food and Drug Administration.
As of June 5, the Food & Drug Administration (FDA) officially made genetic risk assessments exempt from 501(k) premarket approval, as long as the company providing the test has gone through a one-time premarket review of its testing apparatus and at least one test, as reported by Jonah Comstock in Mobile Health News. Officially published in the Federal Registry, the notice finalized a guidance that was originally proposed in November 2017.
Shocking Snails, Making Memories
Researchers from the University of California in Los Angeles (UCLA) showed that they could transfer memories by injecting RNA from one marine snail to another, reported Arlene Weintraub in Fierce Biotech. The researchers hope that the new method could result in new Alzheimer’s treatments.
Gottlieb takes IQVIA to task on Twitter for inaccurate opioid sales data
FDA Commissioner Scott Gottlieb, M.D., has publicly reprimanded IQVIA, a global provider of advanced analytics, technology solutions, and contract research services to the life sciences industry, for providing inaccurate sales data on opioids, including fentanyl.