Join the Festival of Biologics USA 2019

The inaugural Festival of Biologics USA is landing in San Diego on March 4th -5th 2019 (pre-conference day on March 3rd), and we want to make sure you know everything there is to know about this brand-new event.

The Festival of Biologics USA will be combining three high-level commercial events: The Americas Antibody Congress, The Word Immunotherapy Congress, and Clinical Trials USA, under one roof, with 200+ speakers, 600+ attendees and 60+ sponsors and exhibitors.

ASCO, FDA recommend relaxing cancer trial eligibility criteria

A new study found that physicians were less likely to offer clinical trial participation to patients with a comorbidity. The American Society of Clinical Oncology (ASCO), Friends of Cancer Research, and the FDA recently reviewed the comorbid conditions that are generally used in eligibility criteria to exclude patients, and recommended that many be modified or liberalized, which could be necessary to improve study participation. (MEDPAGE TODAY)

ASCO policy statement addresses financial barriers to clinical trial participation

The American Society for Clinical Oncology (ASCO) has released a new policy statement, “Addressing Financial Barriers to Patient Participation in Clinical Trials”, which makes several recommendations to address financial barriers to trial participation.  Among other recommendations, the statement recommends improving payer clinical trial coverage, and transparency regarding out-of-pocket costs. (Healio)

Should FDA’s trial review include economic criteria?

The U.S. FDA’s  formal evaluation process for medical devices looks at safety and efficacy prior to market clearance. Should economic considerations be added as part of the FDA review? Authors of this editorial claim that you can’t gain a complete picture of the comparative performance of a procedure by focusing on health outcomes alone; you also need to examine costs in relation to the outcomes to show cost-effectiveness. (DIAC)

Cancer vaccine is first drug given under “right-to-try” legislation

In November 2018, a cancer vaccine being developed by Epitopoietic Research Corp. became the first drug to be given to a U.S. patient under new “right-to-try” legislation that gives terminally ill patients access to experimental drugs. The right-to-try law dictates that any compound used in this way must have successfully completed Phase 1 safety testing and be under the FDA’s ongoing approval process. (FierceBiotech)

Trial in China of high-tech headband raises privacy concerns

The Massachusetts-based startup BrainCo has partnered with a Chinese school for a trial of its high-tech headband to monitor the brains of schoolchildren in class to make sure they are concentrating. The Focus 1 headband uses electroencephalograph (EEG) sensors to detect brain activity when the wearer is engaged in a task.  The devices were worn by 10,000 schoolchildren aged 10-17 during a recent 21-day trial in China. (DailyMail.com)

Why do Phase 3 trials fail?

Drug development is marked by high attrition rates, and the third phase is the most critical. A recent commentary reviewed high profile cases of failed drugs to identify the sources of late-stage failure, and classified the causes of drug failure into avoidable and unavoidable errors. Avoidable errors arise from a lack of scientific rigour, while unavoidable errors arise due to a deficiency in scientific knowledge. (Medical News Bulletin)

The EMA’s 5 goals: Fostering innovative trial design, exploiting AI, and other recommendations

The EMA recently outlined five strategic goals with a focus on fostering clinical trial innovation, optimizing capabilities in modeling and simulation, as well as exploiting AI and investing in special populations, among other objectives. (Outsourcing-pharma.com)

A primer on gene therapy

The FDA defines gene therapy as a medical technique that works to modify a person’s genes to treat or cure disease. Gene therapy represents a paradigm shift in the U.S. healthcare from chronic, often lifelong treatments to the potential for cure. There are currently 3 FDA-approved gene therapy products on the market, and nearly 2,600 gene therapy clinical trials are in progress or have been completed. (Pharmacy Times)