Can virtual clinical trials be as good as the real thing?

New Reality

 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.

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Attacking Alzheimer’s: Human-on-a-chip model could lead to better treatments

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.

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Theranos Dissolving: Health startup will pay off creditors from remaining cash and cease to exist

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.

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AstraZeneca agrees to pay $110 million for Texas Medicaid fraud suits

Super Settlement

Drug making giant AstraZeneca is prepared to settle two lawsuits in Texas accusing the company of "off-label marketing" of rosuvastatin calcium (Crestor—AstraZeneca) and quetiapine fumarate (Seroquel—AstraZeneca) to Medicaid providers in Texas. The settlement has a hefty price tag of $110 million, according to an announcement by the state attorney general.

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Three AI companies take on metabolism and diseases related to aging

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.

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FDA issues guidelines for cancer drug studies

Seamless Clinical Trials

On August 10 the US Food & Drug Administration (FDA) issued a 14-page “draft guidance” to assist sponsors in designing and conducting first in human (FIH) clinical trials that accelerate “the clinical development of cancer drugs through multiple expansion cohort study designs,” according to an article by Zachary Brennan in Regulatory Focus, an online publication of the Regulatory Affairs Professionals Society (RAPS). RAPS is a global organization of and for those involved with the regulation of healthcare and related products.

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Market research study focuses on clinical trials

Global Growth

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.


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FDA approves extended use of cystic fibrosis drug

Victory for Vertex

The U.S. Food and Drug Administration (FDA) has approved the use of Vertex Pharmaceuticals’ ORKAMBI® for 2- to 5-year-old children with cystic fibrosis (CF) who have two copies of the F508del-CFTR mutation. Applicable to 1,300 children with the most common genetic form of the disease, the drug is the first medicine approved to treat the underlying cause of CF in this population.

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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.

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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.


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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.”

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Breath test detects cancer markers

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.

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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.

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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.

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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.

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Gene editing technology turns cancer cells against themselves

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.

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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.

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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.

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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'."

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