More Xcenda News

Industry analysis suggests that the FDA and global regulatory authorities will require many more REMS programs as part of their overall risk management strategy in the coming years. To meet the growing demand for post-market safety surveillance including REMS-related services, Xcenda is pleased to announce the expansion of our REMS consulting practice, beginning with the addition of Terri Madison, PhD, MPH, as Vice President of Epidemiology and Risk Management.

“As the former President of i3 Drug Safety, Terri is one of the industry's top experts in epidemiology, drug safety, and risk mitigation,” said Bob Mauch, Xcenda’s President. “With an in-depth understanding of the complexities of the US regulatory environment and more than 25 years of experience, Terri brings strong leadership to one of Xcenda’s most important consulting areas.”

Dr. Madison will focus on helping our clients lead the market in the use of evidence-based science and risk management methods to reinforce the safe and appropriate use of their products. With her team, she will help clients find synergy between their health outcomes research, risk-benefit analysis, and patient access strategy. Whether a client has a known safety issue, has gaps in safety information, or wants to be proactive and initiate a risk management strategy, including exploring the potential implications of a REMS program while a product is still in the early development stage, Xcenda can help. Xcenda’s expanded REMS practice is an ideal complement to our robust commercial strategy offering. We are uniquely positioned to help clients develop comprehensive risk management strategies, using REMS programs to support a product’s safe use and, therefore, maximize patient access and product risk-benefit throughout the product life cycle.

“I am delighted to join Xcenda and help lead the expansion of a best-in-class REMS offering,” Dr. Madison said. “I am also excited about the opportunity to work collaboratively with my colleagues at fellow AmerisourceBergen Specialty Group companies to deliver a broad array of safety surveillance and risk management services.”

“I am pleased that Dr. Madison has joined Xcenda, and I am confident that she will succeed in this key leadership role,” said Amy Grogg, Vice President of Xcenda’s Reimbursement and Value consulting practice.

March 10, 2010: New Partnerships Expand Our Global Reach

Xcenda is partnering with Miller Pharma Consulting, a London based firm that delivers worldwide product value strategies to pharmaceutical and biotech organizations.  We will utilize our complementary experience to help manufacturers commercialize innovative healthcare technologies in the U.S. and international markets.  Learn more

February 1, 2010 :  The Medical Group Management Association selects Xcenda consultant as speaker

Donna Gilbert, Senior Director of Provider Reimbursement Services, will present "Consideration for Proactive Practice Management" at the 4 Corners Medical Group Management Association Conference which will take place April 30, 2010.  Learn more at the conference website.

January 10, 2010: The American Academy of Professional Coders selects Xcenda consultant to speak at national conference

Milda Kaitz, an Xcenda Reimbursement and Coding Specialist will present "Coding and Documentation Requirements for Drug Administration Services" at the national conference for the American Academy of Professional Coders.   Learn more about our consulting services related to coding analysis, strategy, and applications

January 2010:  ASCO Gastrointestinal Cancers Symposium

We are pleased to announce that the proprietary data Xcenda collected during the 2009 NMCR Challenging Cases^® series events were featured in a poster presentation at the 2010 ASCO Gastrointestinal Cancers Symposium which was held in Orlando, Florida January 2010. 

Selected from more than 600 submissions, the poster is titled, “Confirmation of deficient mismatch repair (dMMR) as a predictive marker for lack of benefit from 5-FU based chemotherapy in stage II and III colon cancer (CC): a pooled molecular reanalysis of randomized chemotherapy trials.”  

Authors include:  Joel. H. Schwartz¹, Joanne Willey², Mark R. Green², Susan Britton², Kristine E. Lemke², John Marshall³.  1. Mass General/North Shore Cancer Center, Danvers, MA; 2. Xcenda LLC,  Palm Harbor FL; 3. Georgetown University, Washington DC.

The ultimate goal of “personalized medicine” is to be able to apply information from large volume prognostic and predictive indicator studies for the benefit of the individual patient with a particular diagnosis and specific extent of disease. The data in our poster, acquired through our live research vehicle, Challenging Cases in Emerging Data, and presented at the recent 2010 Gastrointestinal Cancers Symposium, focused on the setting of specific patients with completely resected stage II colon cancer.  In this setting, we demonstrated that American medical oncologists do not yet have complete clarity on the utility of microsatellite testing to define a very favorable subset [MSI-high] and a less favorable subset [microsatellite stable] of patients with completely resected stage II colon cancer and the capacity for this type of testing to help inform the decision for observation or adjuvant chemotherapy at the level of the individual patient.

Learn more about the unique methods we utilize to help manufacturers learn what medical providers do, how they do it, and why.