Biomarker-Driven Oncology Trials

The stakes are high as a drug moves through clinical development, which accounts for more than 70% of the R&D cost needed to bring it to market. Oncology drug development has become more challenging in recent years as the competitive landscape for bringing on a first line therapy tightens and the number of oncology trials declines, especially in early clinical development. While pursuing a blockbuster strategy has been successful in the past, increasingly pharma has been forced to re-think how it approaches the development of oncology therapies.

Many of the old, well-tested strategies for developing cancer drugs are no longer relevant, and biomarkers are becoming an integral part of the story. As the biopharmaceutical industry increasingly turns its focus to discovering and delivering targeted, personalized medications, gaining access to patients in a clinical setting requires a new strategy.

Covance has increased its personalized medicine services to help sponsors conduct biomarker-driven oncology trials, in which selecting the right patients, more so than the greatest number of patients, is critical to the trial's success.

Accelerating discovery and delivery

In February 2013, Covance teamed up with M2Gen®, a subsidiary of the Moffitt Cancer Center in Tampa, Florida, to better identify ideal patients for oncology drug trials. M2Gen, a leader in advancing personalized medicine by using high-quality tissue, clinical data, and molecular technology for personalized cancer treatments, maintains a cancer-focused data warehouse for Total Cancer Care®. This data warehouse has highly specific biomarker information on more than 95,000 cancer patients from Moffitt and a consortium of 17 hospitals throughout the United States.

M2Gen's total cancer care data warehouse

M2Gen has been building the Total Cancer Care data warehouse over the past six years, and of the 95,000 patients in it, more than 35,000 tumor specimens have been collected and more than 20,000 molecular data files have been generated from these specimens. As part of Total Cancer Care, patients opt in through consent to be followed for life and donate tissues not used for clinical purposes for molecular analysis and research. As a result, clinical data are captured and maintained over the cancer patient's lifetime. This unique approach has resulted in one of the most robust cancer-focused data resources in the world. The proprietary informatics platform supports a clinical trial matching program that can significantly reduce the timeline for identifying suitable patients for enrollment in clinical trials and improve the design of biomarker-driven trials.

Partnership in Action

M2Gen continually works to add new clinical providers to its network, further expanding access to a diverse patient population for personalized clinical trials. Growth is planned across the United States as well as expansion of the network in key regions such as Asia and Europe.

Covance moves further into personalized medicine

Over the past five years, Covance has conducted more than 130 oncology clinical trials across several tumor types on behalf of biopharmaceutical sponsors. In addition to this therapeutic and clinical trial expertise, through Xcellerate® sponsors have access to the industry's largest knowledge base that enhances the ability to select high performing clinical trial sites.

Increasing return on investment and delivering the right patients faster

The Covance-M2Gen partnership provides two significant benefits to pharmaceutical companies conducting biomarker-driven oncology trials.

Increasing clinical ROI. Covance combines its biomarker and genomic expertise and M2Gen's longitudinal clinical, molecular and specimen data to stratify patients based on specific markers, match the right patient to the right clinical trials and minimize the risk of recruitment failure.

Delivering the right patients faster. Leveraging Covance's network of oncology investigators and M2Gen's ability to rapidly filter criteria ensures that clinical trials are up and running quickly, which saves time and avoids costly study delays.

New approach to patient identification

Given the myriad challenges biopharmaceutical companies face, developing innovative solutions that take time and cost out of the process is imperative. The need for novel cancer treatments, especially those requiring patients in typically smaller populations, shows no sign of decreasing.

Covance and M2Gen expect to help sponsors accelerate their drug development programs, make better decisions, and improve their efforts to develop targeted therapies for cancer patients.

Frank Makosiej, PharmD, is Executive Director, Operations, Planning, and Strategy at Covance, Inc., 210 Carnegie Center, Princeton, NJ, e-mail: frank.makosiej@covance.com. William Dalton, PhD, MD, is Founder and CEO of M2Gen, 10902 N. McKinley Dr,. Tampa Bay, FL, e-mail: william.dalton@m2gen.com.