As the chief medical officer at GSK, Murray Stewart spends most of his time focused on patients. A recent PARADE (Patient Rheumatoid Arthritis Data from the Real World) study, launched last year, was the first time GSK attempted to use Apple ResearchKit in a clinical study. Within 48 hours, the company had over 200 downloads, and was hopeful they would not just receive data from patients, but insightful information.
For the pharma industry to improve clinical trials, as well as the entire drug discovery process, better links need to be forged with stakeholder groups. That’s the conclusion of a new report released by PwC Health Research Institute (HRI) titled, Patient Engagement: Pharma’s Strategy For Success In The New Health Economy. The report is based on an analysis of the state of patient engagement, including an analysis of 21 patient-engagement meetings and data from the FDA’s Orphan Drug Designations database.
Consolidation in the life sciences industry is a fact of life. The recent merger of Quintiles and IMS Health is just the latest in a string of consolidations. Research firm ISR Reports anticipates the merger activity will continue, with large CROs adding companies with complementary services and midsized CROs attempting to quickly gain scale. For sponsors, is this a good time to reevaluate existing CRO relationships?
Clinical Leader news roundup for the week of April 25, 2016, with articles on the FDA rejecting a Duchenne muscular dystrophy treatment, Lilly, Merck, and Pfizer sharing patient recruitment success stories, machines making clinical trials more successful, using cannabis to treat epilepsy, metaform prolonging the effects of old age, and more.
Dr. William Daley, VP of Medical Affairs at Sanofi-Aventis, has agreed to join the Editorial Advisory Board for Clinical Leader. Daley's research interests are in the field of vascular biology and thrombosis as it pertains to lipid metabolism, diabetes, hypertension, coronary blood flow, cardiovascular disease, women's health and the therapeutic applications of information technology.
A promising new diet may work wonders for helping individuals lose weight and fight obesity. The trial will involve taking fecal matter from the digestive tracts of healthy and thin humans, which would then be freeze-dried and put in a pill. Individuals in the study would then ingest the pills. The research does have some validity. Researchers at the Massachusetts General Hospital in Boston have discovered the microbes in digestive tracts of healthy individuals are different from those in obese individuals.
Jennifer Reichuber, co-founder and principal at Altani Associates, has been a consultant to pharma and biotech companies for about four years. Prior to becoming a consultant, she was involved in clinical development at a Big Pharma company for 15 years. Her experience in healthcare, tech, and pharma, and as a consultant, has given her insights into the challenges these companies face, and their outlook on trends for 2016.
Jonathan Zung has logged over 20 years in the pharma industry, and holds a resume that includes executive positions with both Bristol-Myers Squibb and Pfizer. He is currently the VP, Head of Global Clinical Sciences & Operations for UCB and serves as Chair of the TransCelerate BioPharma Operations Committee. I recently spoke with Zung about the trends that he believes have the greatest potential to impact clinical trials in 2016.
I recently spoke to Reichuber about clinical trends we might expect to see in 2016. She feels the industry continues to undergo change in regard to partnering agreements. But are strategic partnerships going away or just evolving? And in what areas do small pharma and biotech firms really need the most help? In this Q&A article, the co-founder and principal of Altani Associates shares her thoughts.
A classic problem in clinical research has been patient awareness. That is one reason why the industry has turned to advertising to get the message about trials out to the patients. But that does not mean we are doing a better job of increasing awareness.
The results of Veeva 2015 Paperless TMF Survey: Annual Report, released during the Drug Information Association’s (DIA) annual meeting, show the industry continuing to move towards a more paperless clinical trial environment.
While absolute cell counts have been a part of diagnosis for a long time, what is new are absolute count relevance to drug discovery and development.
Ask anyone involved with antibody drug conjugates (ADCs), and they will tell you this is an exciting time to be in the market. While there are some concerns about possible regulatory guidance that will eventually be crafted to address this relatively new market, two recent FDA approvals (Adcetris and Kadcyla), and several more products in clinical trials has the future looking bright. Partnerships, such as the ones between Seattle Genetics and Spirogen, Celgene and Sutro Biopharma, and the acquisition of MedImmune by AstraZeneca, have been instrumental in advancing ADCs, and will continue to drive the technology going forward.
The average cost to develop a new drug, for most companies, is in the billions. A key contributing factor to that figure is the cost of enrolling patients. One study has shown that between 2008 and 2011, the cost for a patient in a Phase 1 trial went from $15,000 to over $20,000. For Phase 2 that cost rose from $20,000 to $35,000, and for Phase 3 it rose from $25,000 to $47,000. The smallest increase occurred in Phase 4, where costs rose from $13,000 to $17,000 (see The High Cost of Clinical Research – Who’s To Blame And What Can Be Done?). When a patient drops out of a study, the costs go even higher.
In past years, the DIA Annual Meeting has not disappointed in terms of education tracks and speakers. The 2013 event promises to do the same. This year’s annual meeting, the 49th, will take place over four days and will feature 22 Tracks, more than 250 Educational Offerings, 450 exhibitors, and more than 7,000 attendees. In looking through the meeting program, I noted many sessions that will address hot issues and feature prominent industry speakers. A few that I felt were most noteworthy are mentioned below. As you schedule your time at DIA, I would recommend you try and include them in your plans.