Clinical News Roundup for the week of March 19, 2017 with information on FDA, NIH, clinical trial applications, pharma’s reputation, and an algorithm to make trials safer and less costly.
This article assesses the mobile health apps market, key features of successful apps, and associated timelines and costs for developing apps that engage patients across categories and conditions.
Whether you read Part 1 of this three-part series — and sought pre-IND (Investigational New Drug) feedback from the FDA — or not, let's assume you have your pre-IND ducks in a row. Now you're ready to embark on preparing and submitting the IND application to the FDA, which, if approved, will allow you to test your drug in humans for the first time.
Imagine that after a tedious job interview process you are finally offered what promises to be a fulfilling and rewarding position with a new company. However, after working there for a while, you notice that the employer is only really paying you every three to six months, which has made it difficult to keep up with your bills and to stay financially afloat. You also notice that when you do receive a check from the employer, you have no way of verifying for which days or hours you have been paid since no explanation is sent with the check and you were never told who at the company you could contact for these types of questions.
One of the biggest challenges to the success of new drugs is that approval and uptake rely heavily on the evidence collected during development, yet decisions on the design of clinical trials occur long before much is known about a drug or its effects. The available evidence for existing and potential competing interventions is expanding constantly, raising the stakes for efficient and appropriate study design even further.
At the recent Data & Technology in Clinical Trials conference, I had the pleasure of listening to Aneesh Chopra speak. Chopra is the president of NavHealth and formerly served as assistant to President Barack Obama and Chief Technology Officer of the United States. His speech was electrifying, dynamic, and set the room abuzz.
The biomanufacturing industry is undergoing a major shift, from single-product processes and stainless steel infrastructure to flexible, multi-product facilities using singleuse technology.
The expanding global pharmaceutical industry projects a 4%-6% annual growth and forecasts that it will reach a value of $1T by 2014. By Paul Dupont
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There are many reasons to be excited by the science being presented at this year’s American Society for Clinical Oncology meeting. The data presented at a special section on Saturday morning opened the door to a future when tumor genetics and biomarkers will change the way we think of about cancer treatment. As a physician working in clinical development, there is also the excitement around intriguing new questions that when answered could lead to life-saving treatments unimaginable just a decade ago.
More than 2,000 people packed into a cavernous conference hall at 8 a.m. on Saturday – demonstrating the high level of shared interest in emerging immunotherapies.
From virtual biotech companies to large pharmaceutical companies, outsourcing is a key consideration in clinical packaging and distribution. According to Sherpa Clinical Packaging, although outsourcing is a valuable strategy for companies of all sizes and capabilities, it should be entered into for reasons specific to a company’s requirements.
With thousands of people, hundreds of investigative sites, multiple CROs and various eClinical source systems—all generating massive amounts of data—clinical trials are an enormous undertaking. While leading organizations use Clinical Trial Management Systems (CTMS) to centralize operational data and automate processes so they can make better decisions, a CTMS can be out of reach for many small to mid-size companies, leaving them with isolated spreadsheets and/or inefficient, manual practices.
Clinical trials are not for the faint of heart. Conducting even one clinical trial is a monumental task with complex processes and issues that can surface and derail a study’s timeline. As a result, delays in regulatory filing, market entry, and ultimately, the delivery of new therapies to patients are all too common.
Electronic Data Capture (EDC), which collects clinical trial data electronically rather than on paper, is becoming an increasingly popular solution for streamlining data processing.