1Avoca Quality Summit – Agenda – May 7, 2014 #AQCSummit2014
Overall Theme: Progress through Collaboration – Breaking Down ...
2Avoca Quality Summit – Agenda – May 7, 2014 #AQCSummit2014
9:35 AM - 10:30 AM
Session 1: Quality by Design (QbD) – Implic...
3Avoca Quality Summit – Agenda – May 7, 2014 #AQCSummit2014
12:00 PM - 1:00 PM
Networking Lunch sponsored by
1:00 PM - 2:3...
4Avoca Quality Summit – Agenda – May 7, 2014 #AQCSummit2014
4:00 PM - 4:55 PM
Session 5: Clinical Trial Optimization and “...
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Avoca Quality Consortium Meeting Topics Day 2, May 7

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Avoca Quality Consortium Meeting Topics Day 2, May 7

  1. 1. 1Avoca Quality Summit – Agenda – May 7, 2014 #AQCSummit2014 Overall Theme: Progress through Collaboration – Breaking Down Silos, Advancing Technology, and Building Bridges to Patient Event MC: Pete Taft, CEO, Taft and Partners 8:00 AM - 9:00 AM Registration and Networking Breakfast sponsored by 9:00 AM - 9:15 AM Welcome and Overview • Introductions and Consortium Concepts • Patricia Leuchten, CEO, The Avoca Group 9:15 AM - 9:35 AM Introductory Remarks • Leadership Expectations for the Quality Consortium • Dr. Jeffrey S. Kasher, Vice President, Clinical Innovation and Implementation, Eli Lilly and Company • Review of Program for the Day • Steve Whittaker, Executive Director, Avoca Quality Consortium The Westin Princeton at Forrestal Village 201 Village Boulevard Princeton, NJ 08540 AGENDA MAY 7TH 2014
  2. 2. 2Avoca Quality Summit – Agenda – May 7, 2014 #AQCSummit2014 9:35 AM - 10:30 AM Session 1: Quality by Design (QbD) – Implications for Protocol Development and Clinical Operations within Partnered Outsourced Programs 9:35 am - 9:50 am • This presentation will focus on best-practice concepts for the incorporation of QbD principles and practices into outsourced clinical programs. Opportunities to align and strengthen these capabilities across sponsors, CROs, third-party suppliers, and investigative sites will be discussed. • Coleen Glessner, Vice President, Head of Clinical Trial Process and Quality, Pfizer, Inc. • Janis Hall, Senior Consultant, The Avoca Group 9:50 am - 10:30 am • Panel Discussion: QbD Impact on The Absence of Errors that Matter and Risk Management Moderator • Pete Taft, CEO, Taft and Partners Panelists • Dr. Peter Aurup, Vice President and Head, Global Trial Operations, Merck Research Laboratories • Dr. Stephen Cutler, Group President, ICON plc • Coleen Glessner, Vice President, Head of Clinical Trial Process and Quality, Pfizer, Inc. • Dr. John W. Hubbard, Senior Vice President and Worldwide Head Development Operations, Pfizer, Inc. • Dr. Jeffrey S. Kasher, Vice President, Clinical Innovation and Implementation, Eli Lilly and Company 10:30 AM - 11:00 AM Morning Break 11:00 AM - 12:00 PM Session 2: Quality and Effectiveness from the Clinical Research Sites’ Perspective 11:00 am - 11:30 am • Critical to the concept of breaking down silos and building bridges through patients is the ability of sponsors and providers to effectively partner with investigative sites and investigator networks. The role of the investigative site is pivotal to the ability to enroll clinical trial subjects and to ensure quality and integrity throughout a clinical trial program. This presentation will focus on a case study that will highlight new insights toward effective, quality-based site engagement and generate discussion about how partnership is an essential component to achieve top-tier success. • Jennifer Byrne, CEO, PMG Research, Inc. • Jeff James, CEO, Wilmington Health 11:30 am - 11:40 am • Concepts will be shared regarding a collaborative effort toward the creation of an Investigator Databank • Ibraheem Mahmood, President and CEO, DrugDev.org 11:40 am - 12:00 pm • Moderated and interactive discussion with Q&A from audience Moderator • Steven Whittaker, Executive Director, Avoca Quality Consortium
  3. 3. 3Avoca Quality Summit – Agenda – May 7, 2014 #AQCSummit2014 12:00 PM - 1:00 PM Networking Lunch sponsored by 1:00 PM - 2:30 PM Session 3: Keynote Presentation – Subjects No More - Will Your Trial Meet the Patients’ Eligibility Requirements? Bridging to a Collaborative Patient Centered Future. 1:00 pm - 1:45 pm Keynote Speaker: Jamie Heywood, Co-Founder, Chairman, PatientsLikeMe • This inspirational, uplifting and forward-looking keynote presentation by Jamie Heywood, Co- Founder, Chairman, PatientsLikeMe, co-founder of ALS Therapy Development Institute, and the subject of the biography “His Brother’s Keeper: A Story from the Edge of Medicine” will present opportunities for furthering the collaboration between sponsors, CROs, third-party organizations and investigative sites to ensure the delivery of quality outcomes for patients. Clinical trial optimization and quality management will be considered along with the opportunity to use advancements in technology to serve patients and the industry more effectively. Jamie Heywood will reveal exclusive insights from PatientsLikeMe’s latest research into patients’ experience in trials. He’ll share his thoughts about how today’s generation of activated patients, powered by their use of social media, will set eligibility requirements themselves, and upend our assumptions about how to design, conduct, and maximize value from clinical research. He will also provide insights into the new risks we’ll create if we don’t treat patients as equal partners throughout the discovery process. 1:45 pm – 2:30 pm • Moderated Panel Discussion Moderator • Patricia Leuchten, CEO, The Avoca Group Panelists • Jamie Heywood, Co-Founder, Chairman, PatientsLikeMe • Dr. Jeffrey S. Kasher, Vice President, Clinical Innovation and Implementation, Eli Lilly and Company • Rick Sax, M.D., Senior Vice President, Clinical Design & Reporting Services, Quintiles • Dr. Judy Swilley, Executive Vice President and General Manager, Global Clinical Operations and Alliance Management, INC Research 2:30 PM - 3:00 PM Afternoon Break 3:00 PM - 4:00 PM Session 4: Crowdsourcing Solutions • Attendees will be asked for their help to advance key topics covered during the previous sessions today. Each attendee will be asked to join a group who will be led through a crowdsourcing methodology to identify new approaches that could be developed into a tangible solution for a dilemma many organizations in the industry face in their efforts to ensure quality. Moderator • Pete Taft, CEO, Taft and Partners
  4. 4. 4Avoca Quality Summit – Agenda – May 7, 2014 #AQCSummit2014 4:00 PM - 4:55 PM Session 5: Clinical Trial Optimization and “Out of Industry” Approaches and Examples 4:00 pm - 4:10 pm • Technology – “Match Game” Facilitator • Steven Whittaker, Executive Director, Avoca Quality Consortium 4:10 pm - 4:55 pm • This presentation will provide “out of industry” perspectives about technology, tools and systems, and how these insights apply to the pharmaceutical and CRO industry. Next generation “intelligent” approaches (i.e. approaches that draw from investigator databases, patient databases, and social media) will be discussed. As Jamie Heywood stated, “Wouldn’t it be great if the technology we used to take care of ourselves was as good as the technology we use to make money?” • Steve Sashihara, President and CEO, Princeton Consulting and author of “The Optimization Edge: Reinventing Decision Making to Maximize All Your Company’s Assets” 4:55 PM - 5:00 PM Wrap-up and Close to Session • Pete Taft, CEO Taft and Partners • Patricia Leuchten, CEO, The Avoca Group 5:00 PM - 6:00 PM Cocktail Reception Thank you to our gold summit sponsor

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