Posted by: Audrey Erbes | June 7, 2015

Changing Endpoints for Cancer Trials Discussed Plus Events and Jobs

With changing parameters on what is the best protocol for clinical trials, the question arises if patient centered trials are consistent with need for population based data needed for registration and reimbursement. Ronald Epstein and Richard Street write in their article entitled “The Values and Value of Patient-Centered Care” that “There have been concerns that patient-centered care, with its focus on individual needs, might be at odds with an evidence-based approach, which tends to focus on populations.” But proponents of evidence-based medicine now accept that a good outcome must be defined in terms of what is meaningful and valuable to the individual patient.

In the April 2015 article entitled “Endpoints in Cancer Trials: Putting Patients First,” Brad Thompson, Ph. D. makes case for change in endpoint focus for cancer trials from progression free survival (PFS) and overall survival (OS) to response rate (RR) as primary endpoint and OS as a follow-on endpoint He makes case that if industry changed to RR and the FDA accepted that for registration, there might ultimately be more drugs that can be approved boosted by more patients motivated to participate in trials.

Highlights of Upcoming Week’s Bay Area Meetings

  • East Bay AWIS, Monday Evening, June 8, 2015; Topic: “How to Use Decision Making to be a Collaborative Leader;“ Speaker: Betina Schonberger, Senior Consultant with Interaction Associates
  • Bio2Device Group, Tuesday Evening, June 9, 2015; Topic: “Why Do Women Keep Dying from Breast Cancer?: The Role of Automated Breast Ultrasound Screening (ABUS) in Early Detection;” Speakers: Dennis Meister, Global Product Director, General Imaging Ultrasound at GE Healthcare & Anupam DattaMajumdar, Vice President of Engineering for U-Systems
  • JLABS, Wednesday MidDay, June 10, 2015; Topic: “How To… Set a Regulatory Roadmap;” Speaker: Kathleen H. Gibbon, Director, Global Regulatory Affairs, Janssen Research & Development, LLC
  • Free Bioceutics Webinar, Wednesday Morning, June 10, 2015; Webinar Topic Is Pharma Leveraging the Diagnostic in Targeted Therapy Branding and Communications? “The Pharma Personalized Medicine Branding Report ‘WHO, WHAT AND WHY’;” Speaker: Sanna Paakkonen, EVP, Managing Director, Bioceutics; Paul J Pfleiderer, SVP, Director, Medical Affairs, Bioceutics
  • EPPIC and CBA, Wednesday Evening, June 10, 2015; Topic: “Modern Seafarers: Navigating Life Sciences Investments and Entrepreneurship Between the US and the Far East;” Speakers: Anula Jayasuriya, MD, PhD, MBA, Co-founder of Evolvence India Life Sciences Fund;Jonathan Norris, JD, Managing Director, Healthcare Practice, Silicon Valley Bank; Mohan Uttarwar, Co-Founder & CEO, iNDx LifeCare, Inc.;Jimmy Wei, PhD, MBA, Venture Partner, KPCB, China; Chen Yu, MD, MBA, Managing Partner, Vivo Capital; Moderators: Glen Sato, JD, MBA, Partner, Cooley; Cheni Kwok, PhD, CLP, Managing Partner, Linear Dreams
  • BOLD/WIB, Thursday, June 11, 2015; Topic: “Prioritizing Gender Equity: What does it take to reach and succeed at the “C” and Board level?” Moderator: Heather Erickson is president and chief executive officer of the Life Sciences Foundation; Panelists: Laura Brege, President and CEO, Nodality, Inc.; Mark A. Goldsmith, M.D., Ph.D., President and CEO, REVOLUTION Medicines, Partner, Third Rock Ventures; Wende Hutton, General Partner, Seasoned Strategist, Canaan Partners; ; Kim Popovits, CEO and Chairman of the Board, Genomic Health; Dr. Laura Shawver, CEO, Cleave Biosciences

You can download Audreys Picks June 7, 2015 with complete details on the above and other meetings and conferences through Dec. 2015 by right clicking on the highlighted titles. JobsThatCrossedMyDeskThrough June 7, 2015 is also provided.

Advise colleagues who would like to  access my blog to go to


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