New cloud-based Parexel technology provides better patient interactions

Meaningful Data

Leveraging its relationship with Microsoft to assist with drug development, Parexel has introduced the world to several new patient-centric solutions that utilize its Perceptive Cloud platform. The patient-centric solutions for drug development feature mobile and wearable tech to make access to data for better patient interactions during clinical research faster and better, the company explained.

Read More

Milestone procures $80M to fund at-home phase 3 trial of tachycardia rescue nasal spray

Bringing It Home

Etripamil, a “short-acting calcium channel blocker being developed for paroxysmal supraventricular tachycardia, or PSVT, where the heart can beat over 200 times per minute,” is certainly exciting investors, according to an article by Conor Hale in Fierce Biotech. Milestone Pharmaceuticals of Montreal, Canada, has raised $80 million to fund its lead program, an at-home, phase 3 clinical trial of its nasal spray for rapidly reducing super high heart rates.

Read More

Digital health startups need to analyze stakeholders

Cracking the Code

While some forms of high technology succeed using a “move fast and break things” approach, digital health startups have to go deeper into the requirements of the industry to “truly transform healthcare,” according to an article by Paul Yock, a cardiologist, health technology innovator, professor of medicine and bioengineering and founder of the Byers Center for Biodesign at Stanford University. Dr. Yock, writing in Fast Company (www.fastcompany.com/90251795/why-do-digital-health-startups-keep-failing, said that money and buzz are not enough to be successful in healthcare, “a much more complex and regulated industry.”

Read More

Allogene begins Nasdaq trading at $18 per share

Living Drug

Allogene Therapeutics, a clinical stage biotech company specializing in allogeneic CAR-T (AlloCAR T) treatments for cancer, started trading on the Nasdaq Stock Exchange at $18 per share. The company, which launched in April 2018 with a $300 million Series A financing, is expecting to raise $288 million by selling about 16 million shares, reported Mark Terry in BioSpace.

Read More

Veeva announces single app to manage clinical trial data

Cloud Tool

Veeva Systems Inc. -- a leader in cloud-based software for the global life sciences industry -- is offering a new cloud-based application that combines several of its tools. It includes coding, EDC, data cleaning and reporting. Enabling companies to manage clinical trials from build through execution, the new app is designed to achieve a complete and concurrent view of all clinical data within a trial, according to the company.

Read More

Data Cubed uses gaming technology to facilitate human interaction in clinical trials: Making a Game out of It

Basing its approach on popular computer games, Data Cubed has created a platform that could “increase patient engagement in clinical research,” according to an article by Melissa Fassbender in OutsourcingPharma.com. In 2016 when Data Cubed (D3) was founded, the company took advantage of several trends -- structured big data, mobile technologies, patient-centric care, and social networks, the article explained.

Read More

Uninsured People and Clinical Trials

Both ethical and practical issues raise concerns

 How does an uninsured person’s participation in a clinical trial affect the outcome? Does the lack of affordability of healthcare give rise to untenable situations in choosing participants for clinical trials?

 These were some of the issues addressed by George Marzouka, MD, who wrote an article called “Ethical Concerns Arise in Clinical Trial Enrollment as Number of Uninsured and Underinsured Americans Skyrockets” in Medical Bag recently.

Read More

Innovation in Pharma: Is there a problem, and can it be fixed?

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.”

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.


Read More

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.


Read More

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.”

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More