Bridging Clinical Trial Innovation and Quality

Transcription

1 May 13-14, 2015 (Preliminary Agenda as of April 3, 2015) Bridging Clinical Trial Innovation and Quality The Westin Princeton at Forrestal Village 201 Village Boulevard Princeton, NJ Confirmed Speakers (As of April 3, 2015) John Barry, Head of Vendor Strategy and Management, Global Clinical Development, Merck & Co. Marielle Cohard- Radice, MD, Vice President, Clinical Development Operations, Daiichi Sankyo Pharma Development Jeremy G. Chadwick, PhD, Head, Global Clinical Development Operations, Shire Pharmaceuticals Stephen Cutler, PhD, Chief Operating Officer, ICON plc Brigid Flanagan RN, CCRC, MS, Director, Clinical Development, Frenova Renal Research Joseph Fortunato, Senior Vice President, Corporate Quality Assurance, inventiv Health Clinical Coleen Glessner, Vice President, Clinical Trials Process and Quality, Pfizer Inc. Frances Grote, Senior Director, Clinical Operations Vendor Oversight, Biogen Idec Brian Hagen, PhD, Managing Director, Decision Empowerment Institute Scott A. Harris, Head, Third Parties Quality Management Q&CI, CSO, Sanofi U.S. Jennifer Heckman, Head, Operational Excellence Clinical Development Operations, Shire Pharmaceuticals

2 John W. Hubbard, PhD, FCP, President and CEO, BioClinica Mitchell A. Katz, PhD, Head of Medical Research and Drug Safety Operations, Purdue Pharma L.P. Andreas Koester, MD, PhD, Vice President, Clinical Trial Innovation/External Alliances, Janssen, Pharmaceutical Companies of Johnson & Johnson Jessica Lee MS, MPH, Vice President, Clinical Operations and Compliance, Inovio Pharmaceuticals Craig Lipset, Head of Clinical Innovation, Pfizer Inc. Elizabeth Luczak, Vice President, Regulatory Compliance Quality Assurance, Covance Jeffrey P. McMullen, Chairman, inventiv Health Clinical and Vice Chairman, inventiv Health, Inc. Ann Meeker- O Connell, Head, Risk Management and External Engagement, BioResearch Quality and Compliance, Johnson & Johnson Quality and Compliance Robert Metcalf, PhD, Vice President, Global Regulatory Affairs - US, Eli Lilly and Company Nancy Meyerson- Hess, BA, MPhil, Grünenthal Innovation- Global Late Clinical Development, Head Quality Management, Grünenthal GmbH Dave Nelsen, President, Dialog Consulting Group Adrian Otte, MB, BCh, FFPM, Vice President, Global Development Operations, Amgen Jonathan Rowe, PhD, MS, MA, Head of Quality Performance Management, Pfizer, Inc. Merrick Rosenberg, President and Chief Learning Officer, Team Builders Plus Carla Wandt, PhD, Global Head of Quality Services, PDQ, F. Hoffman- La Roche Nicholas Webb, Innovation Consultant & Corporate Strategist, Senior Partner, Entrepreneur, Keynote Speaker, Best- Selling Author

3 8:30 9: 15 Registration and Continental Breakfast 9:15 9:30 Welcome and Overview of the Day Agenda MAY 13 th :30 10:30 Session 1: Exercise to Introduce the Avoca Quality Consortium Community 10:30 11:10 Session 2: Creating and Implementing a Successful Avoca Quality Consortium Community to Improve Quality in Clinical Trials This session will feature a demo and Consortium Member interactive activity with the community portal that was developed for the AQC, with a user- friendly tutorial on how to engage on the platform to optimize collaboration opportunities with other Consortium Members. The session will provide examples on how to enhance and expand opportunities for AQC networking and information sharing beyond what is currently available at Member meetings. Each attendee will log on with newly provided credentials and actively begin engagement with other attendees. 11:10 11:30 Networking Break 11:30 12:30 Session 3: Rapid Sharing of Content Ideas for AQC Community Portal Part 1: Through a moderated activity, each table will develop rich Consortium content topics that are of interest to the group and may be potential topics to be discussed on the community portal. Tables will then be selected to share one of the topics with the larger group. All topics will be collected by Avoca staff for future reference and moderation of the portal. Part 2: The groups will transition from table discussions regarding rapid sharing of rich content ideas to actively sharing rich content online within the AQC Community Portal.

4 12:30 1:30 Networking Lunch, Sponsored by BioClinica Optional Interactive and Moderated Lunch Table Discussion Topics 1. Innovative Site Engagement Techniques to Improve Clinical Trials 2. Sourcing Models for Small and Mid- size Sponsors: Optimization Opportunities for Performance Enhancement 3. How to Implement a Data- Driven Approach to Monitoring 4. Revolutionizing Approaches to Internal Quality Management Structure 5. Tips for Smaller- Size Companies to Manage Quality in Clinical Research 1:30 2:15 Session 4: Establishing a Holistic Quality Management Framework A Member panel discussion will highlight corporate and partnership approaches for establishing and implementing effective Quality Management Systems or Frameworks to ensure reliable, top- tier delivery of quality within clinical programs. Topics will include: - Integration of quality agreement templates and concepts, QbD principles, leading- practice quality oversight guidelines and tools, outcomes- based quality metrics, and risk assessment/management processes - Lessons Learned on how companies are mapping Quality Requirements into a Quality Management Plan 2:15 3:00 Session 5: Protocol Quality Critical Concepts and Patient Engagement Avoca will share updates on initiatives that focus on Protocol Quality, including assessment, tools and opportunities for patient engagement. 3:00 3:30 Networking Break 3:30 4:15 Session 6: Update on Prequalification Initiative: Development of Core Standards and Technical Standards by Specialty Area (Medical Imaging, Central Labs, ECG, IRT, Biomarker Labs, epro/coa, Bio- analytical labs) - Refinement of existing tools for core standards and taxonomy - Update on expansion into two new specialty areas

5 4:15 5:15 Session 7: Accelerating Learning in Online Communities (None of us is as smart as all of us) Dave Nelsen joined LinkedIn when member numbers were just 5- digits long (his is 98,323). Today there are 350,000,000 LinkedIn members. He started a podcasting company called TalkShoe.com that has been used to create almost 1,000,000 programs now available in itunes (including his 70- part series on winemaking). He was one of the first users of Twitter, which itself started out as a competing podcasting company called Odeo. After more than a decade inside (and helping drive) the social media revolution, his authoritative book on the subject was published in November In his continuously evolving presentation packed with actionable takeaways, Dave shares his insights on how groups can accelerate learning using online communities. He shows (with play- by- play detail) an amazing example of how more than 100,000 people collaboratively discovered the Osama Bin Laden takedown even before President Obama informed the world. Other topics include: LinkedIn highlights, including Groups Blogs, Ning, and GetSatisfaction The Avoca Quality Consortium online community Participation suggestions and benefits If you miss this engaging session on the AQC online community, all of us will be smarter than you. 5:15-5:30 Wrap Up and Closure 6:00 Dinner, Sponsored by Acurian Tre Piani, Italian & Mediterranean Cuisine, Princeton, NJ.

6 Agenda MAY 14 th 2015 Event MC: Craig Lipset, Head of Clinical Innovation, Pfizer Inc. 8:00 9:00 Registration and Networking Breakfast, Sponsored by PPD 9:00 9:20 Welcome and Overview: Introductions and Consortium Concepts 9:20 9:40 Introductory Remarks 9:40 10:20 Session 1: Executive Panel Sponsor/CRO Relationship Management and Impact on Quality Challenges, issues, and opportunities for future state sponsor/cro alliances will be discussed by panel executives, including conversations on how these have shifted over time and how this affects quality. 10:20 10:40 Morning Networking Break 10:40 11:15 Session 2: Presentation and Audience Discussion Risk Assessment This will be a presentation followed by an audience discussion to evaluate leading- practice approaches to risk assessment opportunities for clinical development and partnership constructs between sponsors and CROs. 11:15 12:15 Session 3: Quality Management Systems (QMS): How can Innovation and Integrated QMS Really have an Impact? 11:15 11:30 Presentation: Innovative concepts and approaches regarding the establishment and implementation of an integrated Quality Management System. This will include perspectives from TransCelerate s QMS workstream.

7 11:30 12:15 Panel: An executive panel will discuss practical approaches for the design and implementation of an integrated QMS. Challenges and opportunities will be highlighted, including culture and tangible processes. 12:15 1:15 Networking Luncheon sponsored by ICON Optional Interactive and Moderated Lunch Discussions 1. Taking Measure of Metrics: Learn How to Select and Use Metrics that Work 2. Emerging Sourcing Models and Their Impact on Drug Development 3. Utilization of Leading Practice Tools in Achieving Quality Through Innovation 1:15 2:00 Session 4: Keynote Speaker: Bridging Innovation and Quality - Balanced perspective of an innovator s view and a quality leader s view of how both of these may be integrated and used to collaborate with patients, investigators, and other customers to deliver better value and innovation for all. Nicholas Webb, Innovation Consultant & Corporate Strategist, Senior Partner, Entrepreneur, Keynote Speaker, Best- Selling Author 2:00 2:45 Session 5: Executive Panel: Bridging Innovation and Quality via Clinical Trial Execution and Patient Engagement 2:45 3:15 Afternoon Networking Break 3:15 4:15 Session 6: Presentation and Interactive Audience Session - Strategic Innovation around Protocol Design, Site and Patient Engagement, and Protocol Quality Part 1: Clinical Research as a care option within integrated practice units: innovative avenues to enhance patient outcomes, reduce cost, and drive patient engagement Part 2: This session will utilize an interactive tool to engage the audience and an executive panel into their perspectives about protocol quality and the inclusion of patient perspectives and other critical to quality parameters. 4:15 4:30 Wrap Up and Closure 4:30 7:30 Cocktail Reception, Co- hosted by Avoca and inventiv Health, Inc.

8 2015 Summit Sponsors Platinum Sponsor: Silver Sponsors: Media Partners: Avoca Quality Consortium 2015 Summit, May 13-14