Enhanced Strategies for Design and Execution of Biomarker-driven Oncology Trials

Life Sciences, Clinical Trials, Pharmaceutical, Biomarkers,
  • Thursday, September 12, 2013 | 10am BST (UK) / 11am CEST (EU-Central) / 5am EDT (NA)
  • 0 min

Recording not available for this webinar

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. As the biopharmaceutical industry increasingly turns its focus to discovering and delivering targeted, personalized medicines, many of the old, well-tested strategies for developing cancer drugs are no longer relevant. Gaining access to patients in a clinical setting requires a new strategy, with biomarkers an integral part of the story. The need for novel cancer treatments, especially those requiring patients in typically smaller populations, shows no sign of decreasing.

M2Gen®, a subsidiary of Moffitt Cancer Center, has built the Total Cancer Care TM data warehouse of over 100,000 patients and more than 35,000 tumor specimens, making it the most robust cancer-focused resource of its kind anywhere in the world. A new partnership with Covance can help you translate clinical trial matching expertise and clinical trial design to increase your clinical trial success.

This webinar and panel discussion focuses on new ways to design biomarker driven trials and access the right patients, will demonstrate the power of the Total Cancer Care TM data warehouse, and will feature participation from Millennium Pharmaceuticals.



Kyle Kuvalanka, MBA, VP, Strategy and Business Development, Millennium Pharmaceuticals, Inc.

Kyle Kuvalanka is Vice President, Strategy and Business Development for Takeda’s global oncology business. Mr. Kuvalanka is a member of the global oncology executive team and leads the overall strategic-planning process for the therapeutic area. He also leads the business development team responsible for oncology R&D- and commercial-stage strategic business relationships. Prior to his eleven years at Takeda (including his time at Millennium prior to the acquisition), Mr. Kuvalanka worked in management consulting to the bioPharmaceutical industry. He received an MBA from The Wharton School of Business.

Message Presenter

William (Bill) Trepicchio, PhD, Senior Director, Translational Medicine, Millennium Pharmaceuticals, Inc.

For the past eleven years Dr. Trepicchio has overseen personalized medicine strategies for Takeda’s global oncology clinical development programs. Prior to joining Takeda (and the predecessor company Millennium Pharmaceuticals), he spent eight years at Wyeth Research where he led a number of pharmacogenomics programs. Dr. Trepicchio was a senior fellow of the American Cancer Society and a fellow of the Cooley’s Anemia Foundation at Harvard University. He received his PhD in Human Genetics and Immunology from Tufts University Sackler School of Biomedical Science.

Message Presenter

William Dalton, PhD, MD, CEO, M2Gen and Director, Personalized Medicine Institute at Moffitt Cancer Center

Dr. William (Bill) S. Dalton is past President, CEO & Center Director of Moffitt Cancer Center, an NCI-Designated Comprehensive Cancer Center (2002-2012). He is Founder and CEO of M2Gen, a national biotechnology subsidiary of Moffitt Cancer Center. Dr. Dalton is interested in the development of personalized cancer care and patient-centered outcomes research through Moffitt’s nationally renowned Total Cancer Care TM approach to developing evidence-based, personalized cancer treatments and information/decision tools for patients and clinicians. Total Cancer Care includes one of the largest cancer tumor biorepositories and data warehouses in the U.S. dedicated to the development of personalized medicine. For his leadership in this area, Dr. Dalton was recognized as the 2010 recipient of the Personalized Medicine Coalition’s National Leadership in Personalized Medicine Award. Dr. Dalton’s basic and translational research interests focus on molecular mechanisms of drug resistance and drug discovery. He has over 200 publications, several patents, and has been NIH funded since 1986.

Dr. Dalton currently chairs the Science Policy & Legislative Affairs Committee of the American Association for Cancer Research, as well as serves on the Institute of Medicine’s, National Cancer Policy Forum and various NCI, cancer center and research foundation scientific advisory boards across the U.S.

Message Presenter

Frank Makosiej, PharmD, Executive Director of Operations, Strategy and Planning, Covance

Message Presenter

Who Should Attend?

This program is intended for executives and managers within translational research and clinical operations:

  • Program or product management
  • Clinical operations
  • Project management
  • Oncologists

Xtalks Partners


Covance, with headquarters in Princeton, New Jersey, is one of the world’s largest and most comprehensive drug development services companies, with annual revenues greater than $2 billion and more than 11,000 employees in more than 60 countries. Covance has the people, processes, client service, and global resource capabilities to respond to biotechnology and Pharmaceutical clients’ toughest drug development challenges.


M2Gen, a subsidiary of Moffitt Cancer Center, has developed the Total Cancer Care data warehouse which quickly and precisely matches patients to targeted clinical trials likely to benefit them based on their phenotype and/or genotype. To promote the success of its clients’ enriched trials, M2Gen also provides a suite of trial-related services, making it a “one-stop shop” for critical needs, from preclinical assessment and trial design, to post-trial analytics.

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