DSCS announces “the most practical clinical research conference ever created”

CliniCon19

DSCS Sweat Equity & Investments, LLC, has designed a value-added yearly conference for members of the clinical research community. The company describes it as “what a clinical research conference should be: site-centric, individually focused while catering towards experienced and novice clinical researchers alike, packed with practical and implementable strategies that are proven to produce results, and facilitating networking through arranged "speed dates" at set times.” The conference will be extended online to keep attendees connected with DSCS and each other and to provide “new insights into the industry as they occur in real time.”  

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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.

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FDA suggests heavy fines for not posting clinical trial results online

Transparency 101

The U.S. Food & Drug Administration (FDA) has issued a draft guidance statement proposing heavy fines for pharmaceutical companies and clinical research organizations (CROs) that neglect to post clinical trial results online. According to the statement, the FDA wants to fine organizations that fail to register clinical trials or to report results on to the government database ClinicalTrials.gov as much as $10,000 per day.

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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.

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Forbes contributing writer takes aim at Harvard professor who pans pharma

Disclosure Dilemma

Leading cancer researcher Dr. Jose Baselga, the former chief medical officer of Memorial Sloan Kettering Cancer Center, did not disclose income he received from biopharmaceutical companies in articles that he published in major medical journals and, as a result, resigned from his position. This prompted a scathing response from Dr. Marcia Angell, a senior lecturer at Harvard Medical School and the first woman to serve as editor-in-chief of The New England Journal of Medicine.

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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.

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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.”

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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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