Tufts report cites complexities of clinical trials as source of delays and costs

Complex Clinical Trials

A recently completed analysis by the Tufts Center for the Study of Drug Development cites rising protocol complexity as a key factors that negatively impacts clinical trial performance and efficiency, while driving up the cost of developing new pharmaceuticals, reported Melissa Fassbender in Outsourcing Pharma. The situation could get even worse.

Gottlieb proposes plan to simplify FDA structure

Reorganizing FDA

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.


Market surge creates opportunities and challenges

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.”

Glaxo Smith Kline Invests In 23andMe

Genetics as a Guide

Global drug giant GlaxoSmithKline is investing $300 million in 23andMe, to utilize the consumer genetics company as an exclusive collaborator to facilitate genetics-driven drug research, reported Meg Tirrell of CNBC. UK-based GSK is embarking on a four-year collaboration to discover medicines using human genetics as a guide and could extend the partnership for an additional year. The funding and proceeds will be split equally.

Study shows that female scientists’ career length compares favorably with that of men – once they get their first grant

Gender Issues

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.

Artificial intelligence system projects future symptoms

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.

Sen. Patty Murray reprimands BIO and PhRMA about gender diversity

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.

Google, Amazon, Facebook, and Apple Spur Life Science Growth

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.

Shkreli seems to be sharing biotech tips from prison

Voice Behind the Wall

Does a prison sentence for securities fraud silence somebody who still thinks he has a lot to say? Martin Shkreli, the former pharmaceutical executive who was sentenced to serve seven years for securities fraud, may be blogging biopharma tips from prison, according to Amirah Al Idrus of Fierce Biotech.

In the combative, "insolent" tone that he used outside of the prison walls, somebody who sounds like Shkreli is writing a blog using TRULINCS, a limited e-mail system employed by corrections systems. He sends the posts to a friend, who then publishes them. In the first of these posts, disseminated July 1, Shkreli said, "I’ll be discussing biopharmaceuticals and other topics. I am not recommending any stocks or making investment advice. This is merely me 'thinking out loud'."

Lack of CMC information puts clinical hold on trial

CAR-T Crossroads

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.

Amazon Purchases Online Pharmacy PillPack

Doing Drugs

It has long been rumored that online retail giant Amazon was getting into the $560 billion prescription drug industry. Amazon’s announcement that it was acquiring PillPack, an online pharmacy, dropped shares of Walgreens and Rite Aid by 9 percent and CVS Health by 6.6 percent, reported Claire Ballentine and Katie Thomas of the New York Times.

Amazon health care company announces CEO

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.

FDA guidance makes genetic risk assessments exempt from premarket approval

GHR Guidance

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.

Drugmaker says racism is not caused by Ambien

Sanofi on Side Effects

Drugmaker says racism is not caused by Ambien

The fact that Roseanne Barr made waves by tweeting a negative slur about a member of the Obama administration and then blaming a sleep drug for the lapse is old news. The well-crafted response of the company that makes the drug is a public relations move well worth repeating.