Eli Lilly research focuses on patient needs and partnerships

Participatory Partnering

Emily Kramer-Golinkoff, who was  trained as a bioethicist from the University of Pennsylvania, is “the engine behind a multi-level approach to changing the game for the advancement of treatments for patients with certain protein production mutations of Cystic Fibrosis (CF) called nonsense mutations – all while living with the condition 24/7,” according to an article by Joe Kim in Lilly Trial Guide. Kramer-Golinkoff provides funding for many phases of scientific research, advocates for patients with Cystic Fibrosis, participates in clinical research, influences the design of research, connects disparate scientific fields and scientists and inspires action through her public speaking, Kim said.

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Study merges clinical research investigators data from three government databases

Complete Picture

The three primary U.S. government sources of data about clinical research investigators -- National Library of Medicine: ClinicalTrials.gov, FDA: Bioresearch Monitoring Information System (BMIS)and CMS: Open Payments (Sunshine Act) -- provide incomplete and inconsistent data not linked to data in the other databases. While the FDA is aware of the problems, researchers have used the databases to understand investigator demographics and activities.

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FDA steps up in regulating safety concerns

Data-Driven Progress

The U.S. Food and Drug Administration (FDA) has established a new objective for itself: “to become the international leader in medical device safety through better use of big data,” according to an article by Conor Hale in FiercePharma. The agency has made a commitment to quick device safety responses “using real-world data and active surveillance,” Hale explained.

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Analyst says blockchain technology could help clinical trials

Blockchain Bonanza

Caron Dhillon, a health care analyst at Results Healthcare, believes that the use of blockchain technology could solve many of the challenges of the clinical trials process, according to an article in Outsourcing Pharma by Melissa Fassbender.

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Inspection prompts FDA shutdown: Ketamine Trial Cut Off

In July a consumer rights group, Public Citizen, with 64 doctors, bioethicists and academics, called on the US Food and Drug Administration (FDA) to investigate the Hennepin County Medical Center in Minnesota because of concerns involving informed consent. What resulted was the suspension of a clinical trial, Ketamine Versus Midazolam for Prehospital Agitation.

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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.

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Memorial Sloan Kettering’s Stake in Startup Raises Concerns

More Entanglements?

Memorial Sloan Kettering Cancer Center – one of the nation’s most prestigious institutions – is in the news again. In a New York Times article by Charles Ornstein and Katie Thomas that was reported and written in a collaboration with ProPublica, the nonprofit investigative journalism organization, it is explained that a startup in which the hospital has a financial stake is raising red flags among the institution’s pathologists. The dissension comes on the heels of another ethical question.

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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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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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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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