Three Visuals to Explain the Impact of Pharmacogenomic and Epigenetic Biomarkers in Oncology

This post was authored by Mike Madarasz of the Institute for International Research.  You can follow him on Twitter at @MikeMadarasz

In an effort to increase efficiency and streamline development of effective cancer therapies as well hold down costs associated with conducting clinical trials, drug developers have increased their investment in clinical biomarker research.  Specifically, there has been an increase in the use of pharmagenomic (PGX) biomarkers to either select or stratify patients.  Citeline recently published a white paper outlining some of the major impacts in oncology—some of which are explained in the charts below.

The increase in oncology trials selecting or stratifying by PGBX Biomarkers

The percentage of trials in this category has more than doubled since 2002

Breakdown of countries in PGX trials

The U.S. accounts for nearly 30% of these trials with Japan being the next closest at almost 15%.

Top sponsors using PGX biomarkers to select/stratify patients

The National Cancer Institute comes out as the top sponsor both in the relative     sense and in number of PGX trials.

To check out more from Citeline, download the white paper here.

You can hear more from top industry thought leaders. Check out the Biorepositories and Sample Management Conference. 

September 8-10, 2015 | Boston, MA

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Free Webinar-Breadth and Depth: Oh, What a Data-Rich Biorepository Can Do for Your Research!
DATE: April 30, 2014, 2:00 PM - 3:00PM EST 
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Free Webinar: Breadth and Depth: Oh, What a Data-Rich Biorepository Can Do for Your Research

Mike Madarasz, @MikeMadarasz

Advancements in technology are rapidly increasing the applications for banked biospecimens in research.  When combined with comprehensive data annotation and appropriate study design, biorepository specimens can create an effective research environment.  This approach may help to avoid the challenges of traditional, prospective studies and potentially reduce both timelines and cost.

In our upcoming webinar, Mahesh Krishnan, MD, MPH, MBA, FASN, Vice President, Clinical Innovation and Public Policy for DaVita Healthcare Partners (with moderation by Scott Sibbel, PhD, Associate Director of Epidemiology at DaVita Clinical Research) will delve into the following:

• Overview of how researchers, clinicians, and drug and diagnostic developers can employ banked specimens with comprehensive data annotation to aid in research
• Review of  the model requirements to consider, including evidence of utility, accompanying clinical data annotation, and robust procedures enabling clinical-trial quality
• Common objections to this approach and will include an interactive Q and A session.

DATE: April 30, 2014, 2:00 PM - 3:00PM EST

Register Here

Discount Code: XP1998BLOG

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A Reflection on the BioRepository and Sample Management Conference

About the author: Alex Gelman is the Managing Partner of Poplar Partners, an investment firm looking to acquire a company in the biorepository space. Before founding Poplar Partners, he worked at KKR Capstone, the operating arm of private equity firm Kohlberg Kravis and Roberts, and at McKinsey &Co. He has an MBA from the Stanford Graduate School of Business and a BA from Dartmouth College.

A Reflection on the BioRepository and Sample Management Conference

As I reflect on the Biorepository and Sample Management Conference from a couple weeks ago, I wanted to share some thoughts I had on the conference.

Amelia Wall Warner kicked the conference with a quote from a June 2010 Wired Magazine, “Each vial represents the trace of a human life launched into the future in hopes of a cure that will benefit others”. What an excellent way to kick off a conference that focuses on an industry that is fundamentally dedicated to saving lives. Whether we are involved in the non-profit side or for-profit side, whether we are researchers, physicians, sales reps, or investors, we are all involved in an industry that is fundamentally trying to better the world by finding cures for diseases.

What’s even more impressive is that despite the scientific, legal, technical, and economic complexity of the industry, the ethics of biobanking kept top billing at the conference. In particular two themes jumped out at me regarding ethical issues in biobanking: managing informed consent and improving collaboration.

Ensuring informed consent is given by patients and is tracked with samples was a recurring conversation at the conference. Philip Branton talked about the importance of ensuring informed consent as a criteria for CAP accreditation. Mark Collins told us about BioFortis’ efforts to tie consent to samples to ensure all samples are usable. Lori Ball kicked off the standardization workshop group by asking us to think ‘beyond’ informed consent.

In addition to informed consent, increasing collaboration was a frequent ethical issue that was discussed. Collaboration may not seem like an ‘ethical’ challenge, but with so many dollars, reputations, and prestige at play in biomedical research, collaboration is more challenging than one would hope for. Helen Moore asked us to consider the roadblocks to international collaboration and challenged us to work through them. I was pleasantly pleased to see two different attempts at increasing collaboration, on both sides of the ‘pond’. Franceso Moscone told us about the BIOPOOL project in Europe and Peter Kulseza told us about the NCI/ECOG-ACRIN project hear in the US. At times the room got a bit heated when discussing collaboration and the sharing of valuable samples. That just reinforced the importance of continuing to work at the goal of increased global collaboration.

It truly was a pleasure to see biobanking practioners and those interested in the field coming together to work through the ethical challenges of the industry.

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